Systems and methods for increased operating room efficiency

ABSTRACT

Systems, devices and methods to improve safety and efficiency in an operating room comprise providing a suture package that holds new suture needles and needle receptacles for storing used needles. The devices can be safely worn for the surgeon to self-dispense new suture needles in the near surgical field and to secure the used needles into a needle trap or a needle retainer located on his extremity, on his operative instruments or on the surgical drapes. The device may provide automated and/or simplified needle counting both during use and after removal from the surgical field. The device may be configured for ergonomic and efficient use so as to minimize the actions and motions of the surgeon to dispense and secure the needle.

CROSS-REFERENCE

This application is a continuation U.S. patent application Ser. No.15/221,502, filed Jul. 27, 2016, entitled “Systems And Methods ForIncreased Operating Room Efficiency”; which is a continuation of U.S.patent application Ser. No. 14/697,050, filed Apr. 27, 2015, now U.S.Pat. No. 9,451,949, entitled “Systems And Methods For IncreasedOperating Room Efficiency”; which claims the benefit of U.S. ProvisionalApplication No. 61/984,543, filed Apr. 25, 2014, entitled “System andMethod for Increased Operating Room Efficiency”; U.S. ProvisionalApplication No. 61/984,576, filed Apr. 25, 2014, entitled “System AndMethod For Increased Operating Room Efficiency”, U.S. ProvisionalApplication No. 62/105,540, filed Jan. 20, 2015, entitled “System,Method And Apparatus For Handling Suture Needles In An Operating Room”,and U.S. Provisional Application No. 62/128,856, filed Mar. 5, 2015,entitled “System, Method And Apparatus For Handling Suture Needles In AnOperating Room”, the entire disclosures of which are incorporated hereinby reference.

BACKGROUND OF THE INVENTION

The use of an operating room can present expensive medical servicecosts. It is estimated that operating room time can cost between about$30 to $100 per minute. An operating room must be sterilized before eachoperation and the medical staff must also prepare for the operation.Because each employee is usually paid for their time in the operatingroom, the operating room use costs can be very high. By increasing theefficiency of the employees within the operating room, the time for eachprocedure can be reduced and the cost of the surgery can also bereduced. Further, it is important to account for surgical objects suchas needles and sponges during a surgical procedure. If a needle becomeslost during the surgery, steps need to be taken to ensure patient safetyand that the needle has not been accidently left in the patient.Accounting for needles during a surgical procedure in an accurate mannercan be time-consuming. Therefore, it would be desirable to provideimproved ways to keep track of used needles in an operating room. Also,needle puncture through a surgical glove can present risks to operatingroom personnel.

The process of loading a needle holder is often carried out by thosepersonnel assisting the surgeon in the process of surgery. A scrubtechnician or surgical assistant can pass the loaded needle holder tothe surgeon. Both unused needles not yet having been used and thosealready used needles can be maintained on an instrument tray such as aMayo stand, and an accounting of the needles is often made by thesurgical assistant and circulating nurse during the course of surgery.

At the time of surgical incision wound closure, or other tissue repair,during which multiple armed sutures are to be utilized, the surgicalassistant can be fully focused on the needs of the surgeon. Theassistant passes the loaded needle holder to the surgeon's hand for use.

Used needles may be dispensed and accounted for in a less than optimaland safe manner. As a substitute for having the loaded needle driverpassed to the surgeon, the surgeon may awkwardly load the armed suturehimself. This often requires the surgeon turning to the instrument tray(e.g., Mayo stand), locating the suture package, and grasping andorienting the package such that the needle can be effectively andproperly loaded onto the needle holder, which takes additional time andmovement than would be ideal and undesirably directs the surgeonsattention away from the patient.

In prior neutral zone approach, objects and instruments that are passedbetween a scrub tech and a surgeon must be placed in a neutral zonearea. The process may require a scrub tech to place the object into theneutral zone and the surgeon cannot pick up the object until the scrubtech's hands are removed from the neutral zone. Similarly when thesurgeon no longer needs a surgical object, it is placed in the neutralzone and the surgeon's hand removed. This system is less than idealbecause the surgeon and scrub tech must often be very careful andclearly communicate and look at the neutral zone, away from the site ofthe operation, when any objects are passed. This can be particularlydifficult when trying to perform actions quickly which can easily happenin an operating room procedure, for example when attempting to save apatient's life.

In many currently used suture handling methods and systems, the surgeoncan be handed a needle driver with an armed suture needle. The surgeonmay drive the needle through the flesh of the patient and then hands theneedle driver with used needle to the scrub tech. The scrub tech thenmoves the used needle away from the surgical field and removes the usedneedle. The scrub tech then places a new armed needle in the needledriver and then hands the surgeon the needle driver. The describedprocess is repeated, and results in more movement than would be ideal.

In addition to being highly inefficient, such systems can also have poormicro-ergonomics.

In light of the above, improved methods and apparatus are needed toimprove operating rooms. Ideally such methods and apparatus wouldprovide improved efficiency, outcomes, needle handling, counting, andsafety.

SUMMARY

The present invention relates to systems and methods for increasingoperating room efficiency. Although specific reference is made todispensing and securing needles, the embodiments described herein arewell suited for use with many types of objects used in an operatingroom, such as sharp objects.

Systems and methods for improving operating room efficiency as describedherein improve the manner in which surgeons access and dispose ofobjects used in surgery such as sutures and needles. The methods andapparatus disclosed herein can improve safety by decreasing the numberof needle passes between the surgeon and assistant, and by placingneedles in a receptacle prior to being passed from the surgeon to theassistant.

In many embodiments, a feature of the invention relates to thedispensing and loading of surgical needles that can be facilitated andmade more efficient and ergonomic by associating the needles, suturesand the packaging onto the surgeon's forearm, wrist, and/or hand.Furthermore and in many embodiments, the invention relates to theassociation of used needle temporary storage device as associated withthe surgeon's forearm, wrist, and/or hand. The association of thesurgeon's forearm wrist and/or hand can be accomplished in many ways,such as with mounting onto the surgeon's forearm wrist or hand, mountingto a surgical instrument such as forceps, or with a support extendinginto a near surgical field of the surgeon, and combinations thereof.Packaging and devices as described herein facilitate the safe andefficient dispensing of armed sutures in the proper orientation from thesurgeon's forearm, wrist, and/or hand for use by the surgeon.Alternatively or in combination, the sutures can be dispensed from asupport coupled to a surgical instrument such as forceps and thedispensed needles subsequently placed in the receptacle. The methods andapparatus disclosed herein allow the physician to self-load the needleinto the needle driver, self-place the dispensed needle into a usedneedle receptacle, and optionally install the suture in the patient,which have the benefits of decreasing reliance on assistants, improvingoperating room efficiency and the safety of needle handling. In manyembodiments, one or more needles can be secured in the receptacle priorto passing the needle to an assistant, which increases safety by placingthe needle in the receptacle prior to passing to the assistant. Aplurality of needles can be surgeon dispensed and surgeon placed in thecontainer, such that the safety and efficiency can be increased bydecreasing the number of passes between the surgeon and assistant.

In many embodiments, an “armed” suture comprises a suture that has asurgical needle attached. Furthermore, packages of armed sutures oftencontain more than one such suture and needle. The package may containnot only one, but also perhaps five and possibly more such as 8 or moresutures and needles. In the course of surgery, many such armed suturescan often be used, each needing to be “loaded” onto the needle holder or“needle driver”. The surgeon can hold the needle driver in his dominanthand and a tissue forceps in the non-dominant hand in order tomanipulate and hold tissues to be sutured. Thus the surgeon can use bothhands when suturing to self-dispense and self-secure the dispensedneedles.

By associating the suture packaging and the enclosed armed sutures ontothe surgeon's forearm, wrist or hand, the surgeon can more efficientlyaccess armed sutures for loading onto the needle driver. Furthermore,the surgeon's forearm, wrist or hand can also provide a location forattachment of a used needle temporary or permanent storage device. Inmany embodiments, by associating the suture package to the volar ordorsal-radial region of the surgeon's non-dominant forearm, wrist, orhand, the mechanics of grasping the needle with the needle holder can befacilitated. Such an approach allows the surgeon to instantly reorientthe suture pack and into a more appropriate position such that graspingthe needles with the needle holder is facilitated. Associating thepackage with the surgeon's non-dominant extremity can allow the surgeonto, without significant body motion or without needing to grasp thepackage with his non dominant hand, reposition the needle package andneedles in space such that they are readily accessible to be graspedwith the needle driver.

In many embodiments a forearm-mounted system comprises a needle trapthat can include an integrated suture pack mount that can be easilyattachable to and detachable from a needle puncture resistant barrierworn on a forearm. The puncture resistant barrier provides a stablesurface for dispensing of new sutures/needles from a standard suturepack and securement of contaminated needles after the stitch iscompleted. A benefit of the integration of the suture pack mount withthe needle trap is that this configuration can enable real timeproximity reconciliation within the near surgical field of used andunused needles. Integration of the suture pack mount with the needletrap within the near surgical field enables the surgeon to maintainfocus on the incision closure process without having to divert visualattention to locate the needle securement container and deposit the usedneedles.

In many embodiments, the puncture resistant barrier provides protectionto at least the volar surface of a forearm from inadvertent needlesticks and may also provide additional protection to the dorsal surfaceof a forearm. The puncture resistant barrier can also provide additionalmounting surfaces for tool holders, running-suture spools, or otherprocedure specific materials that are optimally located in the nearsurgical field. The puncture resistant barrier can provide protectionfrom sharps and can be comfortable, anatomically conformal, lightweight,unobtrusive, and quickly attachable to the surgeon's forearm with onehand.

The present disclosure provides multiple concepts, technologies anddevices by which currently available armed sutures and the packages fromwhich they are dispensed can be associated with the surgeon's forearm,wrist or hand for easier and more efficient loading by the surgeon,reducing the need for assistance from the scrub technician. Furthermore,disclosed herein are newly designed suture packages or modifications tocurrently available packages, which can incorporate concepts andtechnologies that allow for easy and efficient attachment of single ormultiple suture packages to the support platform on the surgeon'sforearm, wrist or hand or other support. The embodiments disclosedherein are well suited for use when the surgeon is gowned and gloved.The needle storage devices for dispensed used needles can also beassociated with the surgeon's forearm, wrist or hand, as well asprotective barriers and mechanisms that decrease the likelihood ofneedle stick to the surgeon.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIGS. 1A and 1B illustrate a surgical field and a near surgical field.

FIGS. 1C-1F illustrate a method of using a suture handling apparatus inaccordance with embodiments.

FIG. 2A illustrates a top view of a suture package with needles.

FIG. 2B illustrates adhesive strips.

FIG. 3 illustrates a top view of a suture package attached to a glovewith adhesive strips.

FIG. 4 illustrates a side view of a suture package attached to a glovewith adhesive strips.

FIG. 5 illustrates a top view of a suture package with adhesive regionsfor holding the perimeter of the suture package to a glove.

FIG. 6 illustrates a side view of a suture package with adhesive regionsfor holding the perimeter of the suture package to the glove.

FIG. 7 illustrates a top view of a suture package with needles.

FIG. 8 illustrates a bottom view of a suture package with an adhesive.

FIG. 9 illustrates a side view of a “C” shaped suture package holder.

FIG. 10 illustrates a top view of a “C” shaped suture package holder.

FIG. 11 illustrates a top view of a “C” shaped suture package holderworn over a glove.

FIG. 12 illustrates a side view of a “C” shaped suture package holderwith a suture package worn over a glove.

FIG. 13 illustrates a top view of a platform holding sutures attachedwith straps to a glove.

FIG. 14 illustrates a side view of a platform holding sutures attachedwith straps to a glove.

FIG. 15 illustrates a top view of a magnetic platform attached to aglove.

FIG. 16 illustrates a side view of a magnetic platform attached to aglove.

FIG. 17 illustrates a top view of a multi-layer suture package.

FIG. 18 illustrates a side view of a multi-layer suture package.

FIG. 19 illustrates a top view of a multi-layer suture package attachedto a glove.

FIG. 20 illustrates a side view of a multi-layer suture package attachedto a glove.

FIG. 21 illustrates a top view of a multi-layer suture package with ahook and loop attachment mechanism.

FIG. 22 illustrates a side view of a multi-layer suture package with ahook attachment mechanism.

FIG. 23 illustrates a side view of a lower hook attachment mechanism.

FIG. 24 illustrates a bottom view of a lower hook attachment mechanism.

FIG. 25 illustrates a top view of a multi-layer suture package attachedto a glove.

FIG. 26 illustrates a side view of a multi-layer suture package attachedto a glove.

FIG. 27 illustrates a top view of a used suture container and a suturepackage attached to a glove.

FIG. 28 illustrates a side view of a used suture container and a suturepackage attached to a glove.

FIG. 29 illustrates a front view of an elastic band.

FIG. 30 illustrates a top view of an elastic band.

FIG. 31 illustrates a top view of a suture package held around a wristportion of a glove with elastic bands.

FIG. 32 illustrates a side view of a suture package held around a wristportion of a glove with elastic bands.

FIG. 33 illustrates a top view of a glove having a pocket for holding asuture package and a hole for accessing the sutures.

FIG. 34 illustrates a side view of a glove having a pocket for holding asuture package and a hole for accessing the sutures.

FIG. 35 illustrates a front view of a flip pack suture package.

FIG. 36 illustrates a side view of a flip pack suture package.

FIG. 37 illustrates a top view of a glove holding a flip pack suturepackage.

FIG. 38 illustrates a top view of a platform that includes: toolholders, suture packages and a used needle holder.

FIGS. 39 and 40 illustrate side views of different embodiments ofplatforms having modular attachments.

FIG. 41 illustrates a side view of a platform with an enlarged handportion.

FIG. 42 illustrates a top view of an embodiment of a used needle holder.

FIG. 43 illustrates a side view of an embodiment of a used needleholder.

FIG. 44 illustrates a top view of an embodiment of a used needle holder.

FIG. 45 illustrates a side view of an embodiment of a used needleholder.

FIG. 46 illustrates a top view of an embodiment of a used needle holder.

FIG. 47 illustrates a side view of an embodiment of a used needleholder.

FIG. 48 illustrates a front view of an embodiment of a multi-layerplatform.

FIG. 49 illustrates an embodiments of a platform holding a plurality ofsuture packs, a used suture needle receptacle and tool holders.

FIGS. 50-52 illustrate side views of different embodiments ofmulti-layer platforms.

FIG. 53 illustrates a side view of an embodiment of a multi-layerplatform having modular attachments.

FIGS. 54-57 illustrate top views of embodiments of tool holders onmulti-layer platforms.

FIGS. 58 and 59 illustrate a top view of an embodiment of a suture packcarrier on a multi-layer platform.

FIGS. 60-63 illustrate top views of an embodiment of a suture packcarrier for holding multiple stacked suture packs.

FIGS. 64-67 illustrate side views of embodiments of suture pack carrierson multi-layer platforms.

FIGS. 68-70 illustrate side views of embodiments of multi-layerapparatus that include a dorsum platform and a volar platform.

FIG. 71 illustrates a top view of an embodiment of a multi-layerapparatus that include a dorsum platform and a volar platform.

FIG. 72 illustrates a top view of an embodiment of a platform thatincludes a suture pack holder and a used needle receptacle.

FIG. 73 illustrates a side view of an embodiment of a platform coupledto an arm having an adjustable joint.

FIG. 74 illustrates a side view of an embodiment of a platform coupledto a flexible arm.

FIGS. 75 and 76 illustrate side views of an embodiment of a platformcoupled to an “A” frame structure.

FIG. 77 illustrates a front view of an embodiment of a needle receptacleand suture packet assembly.

FIGS. 78-79 illustrate side views of an embodiment of a needlereceptacle and suture packet assembly.

FIGS. 80-81 illustrate side views of an embodiment of a needlereceptacle and suture packet assembly on a surgical tool.

FIG. 82 illustrates a back view of an embodiment of a needle receptacleand suture packet assembly on a surgical tool.

FIG. 83 illustrates a side view of an embodiment of a needle receptacleand suture packet assembly on a surgical tool.

FIG. 84 illustrates a front view of an embodiment of a needle receptacleand suture packet assembly on a surgical tool.

FIG. 85 illustrates a front view of an embodiment of a needle receptacleand suture packet assembly on a surgical tool.

FIG. 86 illustrates a side view of an embodiment of a needle receptacleand suture packet assembly on a surgical tool.

FIG. 87 illustrates a back view of an embodiment of a needle receptacleand suture packet assembly on a surgical tool.

FIGS. 88 and 89 illustrate side views of an embodiment of a platformwith an inflection point on an arm.

FIG. 90 illustrates a flow chart of a process for using an arm mountedplatform apparatus that includes a suture pack and a needle sharpscontainer.

FIG. 91 illustrates a flow chart of a process for using a tool mountedplatform apparatus that includes a suture pack and a needle sharpscontainer.

FIG. 92 illustrates a top view of an embodiment of a repository housing.

FIGS. 93-95 illustrate side views of an embodiment of a repositoryhousing.

FIG. 96 illustrates a top view of an embodiment of a repository housing.

FIG. 97 illustrates a side view of an embodiment of a repositoryhousing.

FIG. 98 illustrates a top view of an embodiment of a repository housing.

FIG. 99 illustrates a side view of an embodiment of a repositoryhousing.

FIG. 100 illustrates a top view of an embodiment of a repositoryhousing.

FIG. 101 illustrates a side view of an embodiment of a repositoryhousing.

FIGS. 102 and 103 illustrate side views of embodiments of sharpscontainers with perpendicular orientation needles.

FIG. 104 illustrates a top view of an embodiment of a used needlereceptacle with parallel orientation needles.

FIG. 105 illustrates a side view of an embodiment of suture packsattached to a used needle receptacle.

FIG. 106 illustrates a top view of an embodiment of suture packsattached to a used needle receptacle.

FIG. 107 illustrates a side view of an embodiment of suture packsattached to a multi-layer used needle receptacle.

FIG. 108 illustrates a top view of an embodiment of a sharps container.

FIGS. 109 and 110 illustrate side views of an embodiment of a sharpscontainer.

FIG. 111 illustrates a top view of an embodiment of a sharps container.

FIGS. 112 and 113 illustrate side views of an embodiment of a sharpscontainer.

FIG. 114 illustrates a top view of an embodiment of suture packsattached to a multi-layer used needle receptacle.

FIGS. 115 and 116 illustrate side views of an embodiment of suture packsattached to a multi-layer used needle receptacle.

FIG. 117 illustrates a top view of an embodiment of suture packsattached to a multi-layer used needle receptacle.

FIGS. 118 and 119 illustrate side views of an embodiment of suture packsattached to a multi-layer used needle receptacle.

FIG. 120 illustrates a top view of an embodiment of suture packsattached to a multi-layer used needle receptacle.

FIGS. 121 and 122 illustrate side views of an embodiment of suture packsattached to a multi-layer used needle receptacle.

FIG. 123 illustrates a top view of an embodiment of a sharps container.

FIG. 124 illustrates a front view of an embodiment of a sharpscontainer.

FIG. 125 illustrates a side view of an embodiment of a sharps container.

FIG. 126 illustrates a top view of an embodiment of a sharps container.

FIG. 127 illustrates a front view of an embodiment of a sharpscontainer.

FIG. 128 illustrates a side view of an embodiment of a sharps container.

FIG. 129 illustrates a front view of an embodiment of a sharpscontainer.

FIG. 130 illustrates a side view of an embodiment of a sharps container.

FIG. 131 illustrates a front view of an embodiment of a sharpscontainer.

FIG. 132 illustrates a side view of an embodiment of a sharps container.

FIG. 133 illustrates a front view of an embodiment of a sharpscontainer.

FIG. 134 illustrates a side view of an embodiment of a sharps container.

FIG. 135 illustrates a front view of an embodiment of a sharpscontainer.

FIG. 136 illustrates a side view of an embodiment of a sharps container.

FIG. 137 illustrates a side view of an embodiment of a sharps container.

FIG. 138 illustrates a top view of an embodiment of a sharps container.

FIG. 139 illustrates a side view of an embodiment of a sharps container.

FIG. 140 illustrates a top view of an embodiment of a sharps container.

FIG. 141 illustrates a top view of an embodiment of a suture pack.

FIG. 142 illustrates a front view of an embodiment of a sharps containercoupled to a suture pack.

FIG. 143 illustrates an embodiment of a sharps container coupled to asuture pack.

FIG. 144 illustrates a side view of an embodiment of a sharps containercoupled to a suture pack on a surgical tool.

FIG. 145 illustrates a back view of an embodiment of a sharps containercoupled to a suture pack.

FIG. 146 is a block diagram of an integrated suture packet and needlereceptacle 308, in accordance with embodiments.

FIGS. 147A-149 illustrate embodiments of cartridge type sharpscontainers.

FIG. 150 illustrates a cartridge sharps container mounted on a surgicaltool held by a hand.

FIGS. 151 and 152 illustrate an embodiment of a sharps container thatincludes needle locking mechanisms and needle insertion lights.

FIGS. 153 and 154 illustrate an embodiment of a sharps container thatincludes a locking mechanism.

FIGS. 155 and 156 illustrate an embodiment of a sharps container thatincludes needle locking mechanisms and needle insertion indicators.

FIGS. 157-159 illustrate embodiments of connection mechanisms forcoupling surgical tools to cartridge type sharps containers.

FIGS. 160-166 illustrate embodiments of needle receptacles that includefoam covering holes in a receptacle housing.

FIG. 167 illustrates a top view of an embodiment of a needle trapassembly having a suture pack holder coupled via a hinge.

FIG. 168 illustrates a top view of an embodiment of a needle trapassembly having suture pack holders.

FIG. 169 illustrates an exploded top perspective view of an embodimentof a needle trap assembly having a suture pack holder.

FIG. 170 illustrates an exploded side view of an embodiment of a needletrap assembly having a suture pack holder.

FIG. 171 illustrates an exploded bottom perspective view of anembodiment of a needle trap assembly having a suture pack holder.

FIG. 172A illustrates a top perspective view of an embodiment of aneedle trap.

FIGS. 172B-172D show top, side and end views, respectively, of theneedle trap of FIG. 172A.

FIG. 173 illustrates a top perspective view of an embodiment of an upperstructure component of a needle trap.

FIG. 174 illustrates a bottom perspective view of an embodiment of anupper structure component of a needle trap.

FIGS. 175 and 176 illustrate top perspective views of an embodiment of alower structure component of a needle trap.

FIG. 177 illustrates a front view of an embodiment of a needle trap.

FIG. 178 illustrates a cross section side view of an embodiment of aneedle trap.

FIG. 179 illustrates a cross section top view of an embodiment of aneedle slot.

FIGS. 180 and 181 illustrates a block diagram an embodiment of anelectrical needle detection system.

FIGS. 182-184 illustrate an embodiment of a mechanical needle countingsystem.

FIG. 185 illustrates an embodiment of a dye based needle countingsystem.

FIG. 186 illustrates an embodiment a scanner based needle countingsystem.

FIG. 187 illustrates an embodiment a camera based needle countingsystem.

FIG. 188 illustrates an embodiment a pressure based needle countingsystem.

FIG. 189 illustrates an embodiment of a needle counting system withremote monitoring.

FIG. 190 illustrates an embodiment of a needle retainer.

FIG. 191 illustrates an embodiment of a covered needle retainer.

FIG. 192 illustrates an embodiment of a covered needle retainer.

FIGS. 193-194 illustrate an embodiment of a covered needle retainer.

FIG. 195 illustrates an embodiment of a magnetic needle retainer.

FIGS. 196-197 illustrate an embodiment of a magnetic and foam needleretainer.

FIG. 198 illustrates an embodiment of a magnetic and foam needleretainer.

FIG. 199 illustrates an embodiment of a magnetic needle retainer with acover and suture pack clip.

FIGS. 200-201 illustrate an embodiment of an insert and rotate needleretainer.

FIG. 202 illustrates an embodiment of an insert and rotate needleretainer.

FIGS. 203-204 illustrate an embodiment of a needle trap.

FIG. 205 illustrates an embodiment of a needle retainer.

FIGS. 206-209 illustrate embodiments of needle retaining systems.

FIGS. 210-214 illustrate an embodiment of a modular needle retainingsystem.

FIGS. 215-217 illustrate an embodiment of a modular needle retainingsystem.

FIGS. 218-219 illustrate embodiments of dome type needle retainers.

FIG. 220 illustrates an embodiment of a needle retainer system.

FIGS. 221-222 illustrate an embodiment of a needle retainer system.

FIGS. 223-225 illustrate an embodiment of an insert and rotate needleretainer.

FIGS. 226-228 illustrate an embodiment of an insert and rotate needleretainer.

FIGS. 229-230 illustrate an embodiment of an insert and rotate needleretainer.

FIGS. 231-232 illustrate an embodiment of an insert and rotate needleretainer.

FIGS. 233-234 illustrate an embodiment of an insert and rotate needleretainer mounted on a forearm barrier.

FIG. 235 illustrates a top view of an embodiment of a barrier.

FIG. 236 illustrates a top perspective view of an embodiment of abarrier placed on a forearm.

FIG. 237 illustrates a bottom view of an embodiment of a barrier.

FIG. 238 illustrates a side view of an embodiment of a barrier.

FIGS. 239-241 illustrates top perspective views of an embodiment of abarrier with a needle trap and suture packs mounted on the barrier.

FIGS. 242-244 illustrate top perspective view of an embodiment of abarrier with needle retainers, suture pack clips and a tool holder.

FIGS. 245-248 illustrate perspective views of an embodiment of a needleretaining and suture pack clip assembly coupled to a tool mountinginterface.

FIG. 249 illustrates a top view of an embodiment of a barrier.

FIGS. 250-252 illustrates an embodiment of method for securing a barrierto a forearm.

FIG. 253 illustrates a top view of an embodiment of a needle trap andsuture pack carriers mounted on a barrier.

FIG. 254 illustrates a bottom view of an embodiment of a barrier.

FIGS. 255-256 illustrate an embodiment of a barrier placed on a forearm.

FIG. 257 illustrates a perspective view of an embodiment of a needletrap assembly having a tool mounting interface coupled to a surgicaltool.

FIG. 258 illustrates a front view of an embodiment of a needle trapassembly having a tool mounting interface coupled to a surgical tool.

FIG. 259 illustrates a side view of an embodiment of a needle trapassembly having a tool mounting interface coupled to a surgical tool.

FIG. 260 an exploded perspective view of an embodiment of a needle trapassembly having a tool mounting interface.

FIG. 261 illustrates a front view of an embodiment of surgical gownhaving barriers attached to the sleeves.

FIG. 262 illustrates a side view of an embodiment of a sleeve having abarrier.

FIGS. 263-265 illustrate cross section views of barriers coupled tosurgical gown fabrics.

FIGS. 266-267 illustrate an embodiment of a blade ring.

FIG. 268 illustrates an embodiment of a blade ring.

FIGS. 269-271 illustrate an embodiment of a surgical tool cap suturecutter.

FIGS. 272-273 illustrate an embodiment of a surgical tool having anintegrated suture cutter.

FIG. 274 illustrates an embodiment of a surgical tool mounted scissors.

FIGS. 275-278 illustrate an embodiment of a retractable cable mountedscissors.

FIG. 279-280 illustrate an embodiment of a barrier mounted suturecutter.

FIG. 281 illustrates an embodiment of a scissors within a safety guard.

FIGS. 282-285 illustrate an embodiment of a suture cutter.

FIGS. 286-289 illustrate different embodiments of surgical gloves.

FIG. 290 illustrates a cross sectional side view of an embodiment of aneedle trap.

FIG. 291 illustrates a front view of an embodiment of a needle trap.

FIG. 292 illustrates a cross sectional side view of an embodiment of aneedle trap.

FIG. 293 illustrates a front view of an embodiment of a needle trap.

FIGS. 294-297 illustrate cross sectional side views of embodiments ofneedle traps.

FIG. 298 illustrates a front view of an embodiment of a needle trap.

FIG. 299 illustrates a cross sectional side view of an embodiment of aneedle trap.

FIG. 300 illustrates a front view of an embodiment of a needle trap.

FIGS. 301-302 illustrate cross sectional side views of an embodiment ofa needle trap.

FIG. 303 illustrates a cross sectional side view of an embodiment of aneedle trap.

FIG. 304 illustrates a front view of an embodiment of a needle trap.

FIGS. 305-306 illustrate cross sectional side views of an embodiment ofa needle trap.

FIG. 307 illustrates an exemplary embodiment of an integrated sutureneedle dispensing and securing apparatus.

FIG. 308 is a block diagram of a sterile suturing kit in accordance withembodiments.

DETAILED DESCRIPTION

The present invention is directed towards systems and methods forimproving the efficiency of operating rooms. The embodiments disclosedherein are well suited for combination with many prior systems andmethods, such as prior suture packs, prior needle holders, and prioroperating rooms and personnel.

Although specific reference is made to the placement of used needles ina used needle container, the embodiments disclosed herein are wellsuited for use with needles dispensed from a suture pack and placed in aused needle container without suturing the patient, for example.

Definitions

Secure—The needle is secure means that the tip of the needle isprevented from compromising sterility or coming into contact with skinof the patient or surgical staff. When used with the sharps container,the used needle is physically secured from falling out of container.Sharps can include needles and tools or other objects which have one ormore sharp surfaces that can puncture the skin of the patient orsurgical staff.

In many embodiments, a secure needle as described herein is secured toprevent both the leading and trailing ends or tips of the needle fromcoming into contact with skin, gloves, surgical apparel of the surgicalstaff, surgical drape, or patient.

As used herein like characters such as letters and numerals refer tolike elements.

As disclosed herein, a used suture needle encompasses a suture needledispensed from a suture pack.

As used herein the terms “needle driver” and “needle holder” are usedinterchangeably.

As used herein the terms “armed sutures” and “armed needles” are usedinterchangeably.

As used herein the terms “used needled holder”, “needle receptacle”,“used needle receptacle, “used suture needle receptacle”, “sharpscontainer”, “needle trap”, and “needle receptacle means” are usedinterchangeably.

As used herein the terms “suture package”, “suture pack” and “suturepackage means” are used interchangeably.

As used herein the terms “barrier” and “barrier means” are usedinterchangeably.

As used herein the terms “support” and “support means” are usedinterchangeably.

As used herein the terms “platform” and “platform means” are usedinterchangeably.

As used herein “secure” means fixed or fastened so as not to give way,become loose, or be lost.

As used herein “innocuous” means incapable of contact with a humanfinger.

One approach for improving operating room efficiency is to reduce thedependence of the surgeon on the surgical assistant. For example, asurgical procedure can include performing a surgical procedure and thenclosing a patient's surgical incisions after the procedure is completed.The closing generally includes installing surgical sutures to hold thepatient's body tissue together after the surgery. This surgical sutureprocedure can include needles loaded with sutures that are stored in aneedle package and a needle driver. When needed, the surgeon uses aneedle driver to grasp and remove a needle from the suture package. Theneedle point is pressed into the flesh, advanced along the trajectory ofthe needle's curve until it emerges, and pulled through. The trailingthread is then tied into a knot, usually a square knot or surgeon'sknot. Ideally, sutures bring together the wound edges, without causingindenting or blanching of the skin, since the blood supply may beimpeded and thus increase infection and scarring. Placement varies basedon the location, but the distance between each suture generally is equalto the distance from the suture to the wound edge. The most commonstitch is a simple interrupted stitch with the suture thread cut betweeneach individual stitch. Because each stitch may require a separateneedle and the patient may require many stitches, the surgeon may needto handle many different needles. The size and shape of the needles mayalso vary depending upon the patient's needs.

An embodiment, the present invention is directed towards a system forimproving efficiency by eliminating the need for the assistant toprovide needles to the surgeon when closing a patent's surgical wounds.Eyed or reusable needles are needles with holes or eyes, which aresupplied separate from their suture thread. The suture must be threadedon site, as is done when sewing at home. The advantage of this is thatany thread and needle combination is possible to suit the job at hand.Swaged, or atraumatic, needles with sutures comprise a pre-packedeyeless needle attached to a specific length of suture thread. Thesuture manufacturer swages the suture thread to the eyeless atraumaticneedle at the factory. The chief advantage of this is that the doctor orthe nurse does not have to spend time threading the suture on theneedle, which may be difficult for very fine needles and sutures. Alsothe suture end of a swaged needle is narrower than the needle body,eliminating drag from the thread attachment site. In eyed needles, thethread protrudes from the needle body on both sides, and at best causesdrag. When passing through friable tissues, the eye needle and suturecombination may thus traumatize tissues more than a swaged needle, hencethe designation of the latter as “atraumatic”.

There are several shapes and sizes of surgical needles. These include:Straight, ¼ circle, ⅜ circle, ½ circle, ⅝ circle, compound curve, halfcurved (also known as ski), half curved at both ends of a straightsegment (also known as canoe), etc. Subtypes of the ½ circle needleshape include, from larger to smaller size, CT, CT-1, CT-2 and CT-3. Theski and canoe needle design allows curved needles to be straight enoughto be used in laparoscopic surgery, where instruments are inserted intothe abdominal cavity through narrow cannulas. Needles may also beclassified by their point geometry, examples include: taper (needle bodyis round and tapers smoothly to a point), cutting (needle body istriangular and has a sharpened cutting edge on the inside curve),reverse cutting (cutting edge on the outside), trocar point or tapercut(needle body is round and tapered, but ends in a small triangularcutting point), blunt points for sewing friable tissues, side cutting orspatula points (flat on top and bottom with a cutting edge along thefront to one side) for eye surgery, etc. Atraumatic needles may bepermanently swaged to the suture or may be designed to come off thesuture with a sharp straight tug. These “pop-offs” are commonly used forinterrupted sutures, where each suture is only passed once and thentied.

In an embodiment, operating room efficiency can be improved by allowingthe surgeon to load suture needles to a needle driver. A surgeon may usea dominant hand to hold the needle driver and one or more suture packetscan be attached to the non-dominant limb of the surgeon. The surgeon canthen grasp the new suture needles from the suture packet on thenon-dominant limb.

For example, if the user is right handed, the surgeon may attach thesuture package to the left arm or hand and use the right hand to handlea needle driver. The user can grasp a portion of a needle with theneedle driver and remove the needle from the suture package. The usercan then use the needle driver to press the needle point into the fleshof the patient. The needle is advanced along the trajectory of theneedle's curve until it emerges from the flesh, and the needle andsuture are pulled through. The trailing thread is then tied into a knot,usually a square knot or surgeon's knot.

It has been estimated that there are over one billion passages ofneedles per year in the US. This high needle use results in a seriousrisk of injury. The inventive system reduces this risk because theneedles are only handled by the surgeon. Because there is a reducednumber of passes of sharp needles between surgical personnel there arefewer chances of having accidentally dropped needles, drape penetrationor retained foreign objects within the patient.

FIGS. 1A and 1B illustrate a surgical field and a near surgical field.FIG. 1A illustrates a perspective view and FIG. 1B illustrates a topview of a surgeon performing an operation within the near surgicalfield, using methods and apparatuses in accordance with embodiments. Thesurgeon of FIG. 1A is shown holding a needle driver with his dominantright hand, while holding a tissue forceps with his non-dominant lefthand. A suture handling apparatus in accordance with embodiments isshown mounted on the surgeon's non-dominant left forearm. The surgeon ofFIG. 1B is shown holding a needle driver with his dominant left hand,while holding a tissue forceps with his non-dominant right hand. Asuture handling apparatus in accordance with embodiments is shownmounted on the surgeon's non-dominant right forearm. As shown in FIGS.1A and 1B, the suture handling apparatus as described herein can besupported on a surgeon's non-dominant limb so that the surgeon mayperform maneuvers for an operation using his dominant hand, regardlessof whether the surgeon is right-handed or left-handed.

A “surgical field” can include a space within an operating room wherethe patient and surgeon are located during surgery. A “near surgicalfield” 313 can be a much smaller space that is in close proximity to theincision 317 on the patient 315 and the surgeon. The near surgical field313 may comprise a space disposed between the surgeon 319 and theincision 317. For example, the near surgical field can comprise a length316 extending between a surgeon and an incision of a patient and a width318 extending transverse to the length, the width comprising no morethan about 24 inches (61 cm) across. The entire near surgical field canalso be within the field of view 311 of the surgeon 319.

The near surgical field may be conceptualized as the space bound by theneutral planes 320 of the surgeon's arms, such that no external rotationof the arms or the shoulders beyond a position of neutrality isnecessary for the surgeon to reach an object positioned within the nearsurgical field. For example, the near surgical field can comprise aspace wherein the surgeon's arms retain some degree of bending and canrotate internally from the neutral planes 320 (in the direction shown byarrows 322 in FIG. 2B). Frequently, a surgeon's arms may be in a neutralposition, for example with the arms positioned at the sides and theelbows bent at about 90 degrees. From this neutral position, the nearsurgical field 313 can comprise the space between the edges of theelbows to the tips of the fingers, and about 6 inches beyond the tips ofthe fingers. Generally, the surgeon does not have to engage gross motorcontrol in order to reach an object positioned within the near surgicalfield. On the other hand, to reach for an object positioned outside thenear surgical field, a surgeon would generally be required to engagegross motor control. Since a surgeon usually engages only fine motorcontrol during the performance of a surgical operation, it is desirablethat the surgeon not be required to reach for an object positionedoutside of the near surgical field during the operation, in order toprevent interruptions to the surgeon's workflow. The practice of passingindividual suture needles between a surgeon and an assistant oftenrequires the surgeon to reach outside of the near surgical field,therefore breaking the surgeon's workflow, in addition to exposing boththe surgeon and the assistant to risks of needle-stick injury during thepassing of the needles.

As shown in FIGS. 1A and 1B, the embodiments described herein can allowa surgeon 319 to work within the near surgical field 313 without havingto pass individual suture needles in and out of the near surgical field.The surgeon can be provided with a support comprising platform 145 asdescribed herein, shown mounted on the volar forearm of the surgeon 319in FIGS. 1A and 2B. Platform 145 can support a suture pack 101 and adispensed needle receptacle 157, for example. In many embodiments, whenthe platform 145 is used by the surgeon 319 to install sutures, theplatform 145, incision 317 and the surgical tools 201 will all be withinthe near surgical field 313 and the field of view 313 of the surgeon319, for example. In many embodiments, the near surgical field 313 iswithin about 2 feet of the incision 317. Alternatively or incombination, the near surgical field 313 can be within about 1.5 feet ofthe incision 317. The near surgical field 313 can be within 1 foot ofthe incision 317, for example. According to present embodiments, thesurgeon can perform procedures requiring the use of suture needles bydispensing suture needles from the suture pack 101 mounted within thenear surgical field 313 (e.g., on surgeon's forearm), and securingdispensed needles in a needle receptacle 157 also mounted within thenear surgical field.

In many embodiments, a needle trap or needle receptacle as describedherein is configured such that a user can slide a needle into thereceptacle and have the needle be secured the moment the needle isreleased from the needle driver. The needle can be released using asingle maneuver, and the needle can be immediately secured within theneedle receptacle.

FIGS. 1C-1F illustrate a method of using a suture handling apparatus 305in accordance with embodiments. FIG. 1C shows a surgeon grasping anunused suture needle 103 from a suture pack 101, using a needle driver327 usually held with the user's dominant hand. FIG. 1D shows the needledriver 327 holding the dispensed suture needle 104, having suture 155attached to the trailing end 325 of the suture needle. The leading end323 of the suture needle can be inserted into the tissue 321 near thesite of an incision 317, to install the suture and therefore close theincision. FIG. 1E shows the suture needle 104 having been advanced intothe tissue 321 through the incision 317, to install the suture 155 inthe tissue. The needle driver 327 can be used to grasp the leading end323 of the suture needle 104 as the needle emerges out from the tissue,and pull the needle up and out of the tissue. FIG. 1F shows the surgeonsecuring the suture needle 104, held by the needle driver 327, into aneedle receptacle 331. For example, the user can place the needle 104 inan entry zone 333 of the needle receptacle 331, align the tip of theneedle driver 327 with a slot 343 in the needle receptacle 331, thenmove the needle 104 into a secure zone 337 of the needle receptacle bymoving the needle driver 327 in the direction shown by arrow 329. Asshown by the workflow illustrated in FIGS. 1C-1F, using the apparatus305, a surgeon can dispense a suture needle and securely store thedispensed suture needle by himself, without having to receive a freshneedle passed from, or pass the used needle back to, an assistantlocated outside the near surgical field.

In addition to the improved safety, the inventive system improves theefficiency of surgical procedures, which can result in reduced time forprocedures in the operating room. For example, the time of the surgicalprocedures can be reduced because the scrub tech no longer needs toassist the surgeon with needle loading/unloading, providing needleholders and scissors. Rather than assisting the surgeon, the scrub techcan perform other tasks reduce the time needed in the operating room.For example, the scrub tech can perform a sponge count with thecirculating nurse or begin the breakdown of the back table to facilitatea faster operating room turnover thereby decreasing the time spentbetween surgical procedures. This extra free scrub tech time may alsolead to more accurate and reliable sponge count thereby decreasing therisk of retained foreign object. The overall effect of the inventivesystem and apparatus is faster time of closures (room turnover from onesurgical case to the next) because the scrub tech is also now free tobegin “breaking down” the back table where instruments are kept). Thework flow in the operating room is more efficient because there arefewer steps and no reliance on the support of a scrub tech. Rather thancoordinating the movement of the needles and tools, the surgeon cansimply reach for the needed objects without having to wait for anyoneelse. There is no need to reach for tools and there is no transfer ofsharp objects. The platform can be configured with the properinstruments and/or with needles in an optimum position for removal fromthe suture packs.

Because the surgeon does not need to worry about the coordination oftransferring tools and needles, the surgeon can maintain eye contact onsurgical field. Time lost to looking away from the surgical field orrefocusing the eyes to see where the tools and needles are locatedduring an object transfer can be reduced. Body rotation of the surgeoncan be decreased, as well as crossover of one forearm over the other.The movements can be more circular, of lesser excursion. Thus, themicro-ergonomics can be improved.

Further, the present embodiments can allow the surgeon to track his ownneedle usage and inventory, since the surgeon himself can dispense freshneedles and secure used needles. When needles are passed back and forthbetween a surgeon and an assistant, it can be difficult for the surgeonto know how many more suture needles remain inside an opened suturepack, how many suture packs are opened, etc., while it can be similarlydifficult for the assistant to know how many and/or what types ofneedles have been used by the surgeon. Such lack of clarity regardingthe inventory of available needles can necessitate an ongoing dialoguebetween the surgeon and the assistant, which can be distracting,inefficient, and prone to producing errors. By contrast, when thesurgeon is able to track his own needle usage, as with the methodsdescribed herein, he can easily determine when a particular suture packneeds to be replaced, and communicate his needs to his assistant in amore precise manner. Referring again to FIGS. 1A and 1B, preferably, oneor more new suture packs 101 may be provided on an instrument tray 307(e.g., Mayo stand) located just outside the near surgical field 313. Thesuture packs may be labeled or color-coded to facilitate theidentification of their contents, so that a surgeon can precisely pointout to the assistant which suture pack he needs. The assistant can thenreadily hand the requested suture pack to the surgeon, or the surgeonmay reach for and grab the necessary suture pack himself.

With reference to FIG. 2A, a top view of a suture package 101 isillustrated. The suture package 101 can contain needles 103 threaded orswaged to sutures. The needles 103 can be releasably attached to suturepackage 101 that can include a flat surface that can be flexible to bendto a contour that matches a portion of the user's limbs. FIG. 2Billustrates steri-strips which can be adhesive tape 105 or film that canbe used to secure the suture package 101 to a glove 107 of a user asshown in FIG. 3 which illustrates a top view of a glove 107 and FIG. 4which illustrates a side view of the suture package 101 on the glove107. The adhesive side of the tape 105 can be attached over the edges ofthe suture package 101 and portions of the glove 107.

With reference to FIGS. 5 and 6 another embodiment of the suture package101 is illustrated. In this embodiment, a film adhesive or an adhesive109 applied to the back surface perimeter of the suture package 101.FIG. 5 illustrates a top view and FIG. 6 illustrates a side view of theglove 107 and at least a portion of the perimeter of the suture package101 attached to the glove 107 with the adhesive 109. Alternatively withreference to FIGS. 7 and 8, an adhesive 111 can be applied directly tothe back of the suture package 101. FIG. 7 illustrates a top view of thesuture package 101 and FIG. 8 illustrates a bottom view of the suturepackage 101 with the adhesive 111 applied. In all of these examples, theadhesive that can be used to attach the suture package 101 directly tothe glove 107.

FIG. 9 illustrates a front view and FIG. 10 shows a top view of anembodiment of a “C” shaped holder 113 that can be used to hold suturepackets 101. The “C” shaped holder 113 can wrap around a portion of theuser's hand as shown in FIGS. 11 and 12. FIG. 11 shows a top view andFIG. 12 illustrates a side view of “C” shaped holder 113 on a glove 107on the user's hand. The holder 113 can be made of a flexible materialthat inherently retains its C shape and includes a clip 115 on an outersurface. The holder 113 can be placed on the hand and a suture package101 can be attached to the clip 115, which can include a spring and ahinge 117. The clip 115 can hold the suture package 101 in place so thatthe needles 103 can be grasped with the needle driver as describedabove. If the user runs out of needles 103, the original suture package101 can be removed from the clip 115 and replaced with a new suturepackage 101 with additional needles 103.

FIGS. 13 and 14 illustrate another embodiment of the suture package 101system, which can include a platform 119, and straps 121 that wrap atleast partially around the glove 107 on the user's hand. FIG. 13 shows atop view and FIG. 14 illustrates a side view of the platform 119, andstraps 121 that wrap at least partially around the glove 107. The suturepackage 101 can be attached to the platform 119 in various ways, such aswith an adhesive, straps, etc. The needles 103 can be grasped asdescribed above. If the user runs out of needles 103, a new suturepackage 101 can be attached to the platform or the used platform can bereplaced with a new platform having additional needles 103.

With reference to FIGS. 15 and 16, in another embodiment, a magneticsystem can be used to secure the suture pack 101 to the glove 107. FIG.15 shows a top view and FIG. 16 illustrates a side view of the magneticsystem used to secure the suture pack 101 to the glove 107. A firstpermanent magnet 123 can be secured to the glove 107 and a correspondingpolarity permanent magnet 125 can be attached to the suture pack 101.The polarities of the permanent magnets 123, 125 can be arranged so theback of the suture pack 101 is attracted to the glove 107. The magnets123, 125 can be attached to the glove 107 and suture package 101 withany suitable connection mechanism including adhesives, pockets, clips,etc. When the suture pack 101 runs out of suture needles, the surgeoncan remove the empty suture pack 101 by pulling the suture pack 101 witha force greater than the magnetic force and placing a new full suturepack 101 on the magnet 125.

With reference to FIGS. 17 and 18, the suture pack 101 can includemultiple layered sheets of materials with each sheet holding a set ofneedles 103 and sutures. FIG. 17 illustrates a top view and FIG. 18illustrates a side view of the multiple layered suture package 101. Thismultiple layer suture package 101 can be attached to the glove 107 asshown in FIGS. 19 and 20 in any manner described above. FIG. 19illustrates a top view and FIG. 20 illustrates a side view of themultiple layer suture pack 101 attached to the glove 107. The user canuse the needles 103 on the top layer of the suture package 101. Whenthese first layer needles 103 are used, the user can remove and discardthe depleted top layer suture package 101. The underlying layer can thenbe exposed and the needles 103 stored on the second layer of the suturepackage 101 can be used. This process can be repeated until all of thelayers of the suture package 101 are used.

In an embodiment shown in FIGS. 21-24, a suture pack 101 can have a hookand loop connection mechanism to couple the suture pack 101 to the glove107. FIG. 21 illustrates a top view of the suture pack 101 and FIG. 22illustrates a side view of the suture pack 101. In this embodiment, ahook or loop material can be attached to the back of the suture package101 and a corresponding loop or hook material can be attached to theouter surface of the glove where the suture package 101 is to beattached. In the illustrated embodiment, the hook material 127 isattached to the bottom of the suture package 101. FIG. 23 illustrates aside view of the loop material 129 and FIG. 24 illustrates a bottom viewof the loop material 129 with an adhesive 131 applied to the back of theloop material 129. FIG. 25 illustrates a top view and FIG. 26illustrates a side view of the suture pack 103 attached to the glove 107with the hook and loop connection mechanism. When the needles 103 in thesuture package 101 are depleted, the suture package 101 can be replaced.

In an embodiment shown in FIGS. 27 and 28, a needle storage unit 133 canbe secured to the hand in addition to the suture package 101. Theoperating efficiency can be further improved by having the suture packs101 and used needle storage unit 133 in close proximity to the surgeon.The platform 145 can be attached to the non-dominant limb of thesurgeon. The surgeon can then grasp a needle 103 and suture from asuture packet 101 on the platform 145. The surgeon can install thesuture on the patient and then place the used needle 104 in the usedneedle storage unit 133. The surgeon can then grasp the new sutureneedles 103 from the suture packet 101 on the platform 145 worn on thenon-dominant limb.

The needle storage unit 133 can hold the used needles 104 after thesuture has been knotted and the needle is no longer needed. The needlestorage unit 133 eliminates the need to place the used needle 104 in theneutral zone and picked up by the surgical staff after it has been used.The user can simply complete the suture stitch, cut the suture and placethe used needle 104 in the needle storage unit 133 with the needledriver. The user can then grasp the next needle 103 from the suturepackage 101. The needle storage unit 133 can greatly increase theefficiency of the surgical procedure. In an embodiment, the needlestorage unit 133 can include an internal volume and internal walls witha hole or slot for inserting the used needles 104. The housing may betransparent so the user can see that the used needles 104 are fullyinserted and trapped within the needle storage unit 133.

With reference to FIGS. 29 and 30 elastic bands 135 can be used tosecure the suture package 101 to the glove 107 or wrist of the user. Theelastic bands 135 can be a uniform loop or elongated structures thathave a connection mechanism such as a strap buckle or a hook and loopconnection so that the tension of the elastic bands 135 can be adjustedaround the user's hand and/or arm. The bands 135 can be attached toopposite edges of the suture package 101 as shown in FIGS. 31 and 32.

In an embodiment, the suture package 101 can be held in a pocket 137 inthe glove 107 as shown in FIGS. 33 and 34. The suture package 101 can beplaced into the pocket 137 through a slot 139 so that at least thepocket material covers some of the suture package 101. A window 141 orwindows can be formed in the pocket so that the needles 103 areaccessible. The pocket 137 can securely hold the suture package 101 andallow a user to remove the needles 103 from the suture package 101 asdescribed above. If additional needles 103 are required, the suturepackage 101 can be removed from the glove pocket 137 and replaced with anew suture package 101.

In an embodiment shown in FIGS. 35 and 36, the suture package 103 caninclude multiple layers that each holds a set of needles 103. The layerscan be attached to a hinge unit 106 so that the user can flip throughthe different layers like a “Rolodex.” As discussed above, there aremany different types and shapes of needles 103. In an embodiment,different needles 103 can be stored on the different layers of thesuture package 102. With reference to FIG. 37, the multi-layered suturepackage 102 can be attached to the glove 107 in any of the waysdescribed above. For example, a bottom layer of the suture package 101can be held in a slot 139 pocket formed in the glove 107. A mechanismsuch as a hook and loop connection can be used to hold the bottom layerin the pocket.

As discussed above with reference to FIGS. 13 and 14, a platform havinga suture package can be attached to a glove on a hand. In otherembodiments, the platform can include various other componentsincluding: tool holders, suture packs and used needle holders. Forexample with reference to FIG. 38 a top view of a multiple componentplatform 145 is illustrated. The platform 145 can include a first toolholder 147 for holding a first tool 151 and a second tool holder 147 forholding a second tool 151. During a procedure the surgeon can insert afirst tool 151 into a first tool holder 147 and remove a second tool 151from a second tool holder 147. Because the first and second tools 151are easily accessible, there is no need for an assistant to handle thetools 151 as the surgeon switches between the tools 151. A suture pack101 holding suture 103 and a used needle storage unit for storing usedneedles 104 can also be attached to the platform 145.

In an embodiment, the tools 151 can be needle drivers that have handleat a proximal end and a thin tip at a distal end. The tool holders 147can be holes or slots that are wider than the distal portion of the tool151. The distal ends of the tools 151 can be inserted into the holders147 in the platform but the handle portions of the tools 151 can bewider than the holes or slots. The center of balance of the tools 151can be inserted through the holes or slots so that when the platform isupright, the tools 151 will be held in the tool holders 147. In anembodiment, the slots can be between about 0.5 to about 2.0 inches inwidth.

A surgeon can use a platform for holding suture packages during amedical procedure. The suture holders can be attached to a platform 145that is secured to the glove 107 around the hand/arm 143 of the user. Inan embodiment, the platform 145 can be much larger than a single suturepackage 101. In these embodiments, multiple suture packages 101 can beattached to different areas of the platform 145. A surgeon can have aplurality of suture packages 101 on the dorsal surface of the left handglove 107. The right hand is holding a needle driver, which is holding aneedle. The right hand is also holding a tool. The surgeon can completea stitch and then release the needle. The needle driver can grasp a newneedle from the suture package 101.

FIG. 38 illustrates a top view of an embodiment of a platform 145secured around an arm that includes modular attachments. In thisexample, a tool holder 147, suture package 101 and a used needle holder149 are mounted on the platform 145. FIGS. 39-41 illustrate side viewsof different embodiments of platforms 145 that are secured to arms 143of surgeons. FIG. 39 illustrates a side view of an embodiment of theplatform 145 with the tool holder 147, suture package 101 and a usedneedle holder 149 are mounted on the platform 145. The platform 145 canbe a thin structure that can have planar surfaces for mounting themodular attachments in any locations desired by the surgeon. The portionof the platform 145 that is on the forearm 143 can be secured close tothe dorsal surface up the wrist portion of the arm 143. However, theplatform 145 may also include a wrist and hand portion 146 that isangled away from the upper dorsal surface of the hand 144. This spacedconfiguration allows the user to move the hand 144 freely withoutcontacting the bottom surface of the platform 145. In an embodiment, thebottom surface of the platform 145 can be between about 1 to 4 inchesaway from the upper surface of the hand 144 in the normal straightposition.

FIG. 40 illustrates a side view of a platform 145 with a first suturepackage 101, a used needle holder 149, a second suture package 101 and aswaged needle holder 153 with an attached suture. In this example, theswaged needle holder 153 can be include a permanent magnet that holdsthe needle temporarily and the end of the needle 103 can protrude fromthe needle holder 153 so the needle 103 can be easily grasped again. Thesurgeon can place the needle 103 on the swaged needle holder 153,release the needle 103 and tie the suture 155. The surgeon can thengrasp the needle 103 with the needle driver and insert another stitchthrough the patient and repeat the described process. The platforms 145can have various different curvatures so that a surgeon can select aplatform 145 that best suits the personal preference. FIG. 41illustrates a side view of a platform 145 having a substantiallydifferent size and curvature shape.

Different structures can be mounted on the platforms 145 depending uponthe preference of the surgeon. For example with reference to FIG. 40,the platform 145 can include a two suture packages 101 arranged side byside and a needle container 149 on the hand portion of the platform 145.Using the illustrated platform, the surgeon can select different typesof needles and then place the used needles 104 in the needle container149 after each is used. The surgeon can then grasp additional needles asthey are needed. Alternatively in other embodiments, the platform 145can include a suture package area on the proximal portion of theplatform 145, a tool holder at a wrist portion of the platform 145 and aneedle container 149 on the hand portion 146 of the platform 145.

As discussed above, the surgeon can place used needles 104 into theneedle container 149 and then use a second tool as needed. FIGS. 42-47illustrate different embodiments of the used needle holders. It isextremely important to account for all needles during the surgicalprocedure. If a needle becomes lost during the surgery, the needle mustbe found and it may become necessary to x-ray the patient to determineif the needle has been left within the body. The used needle holder canprovide various features, which can make the used needle count easier.

FIG. 42 illustrates a top view and FIG. 43 illustrates a side view of anembodiment of a used needle holder 149 having a plurality of individualneedle receptacles 157. Each receptacle 157 can include a conical holethat can easily accept the tip of the needle 104. The lower portion ofthe conical hole can clam around the sides of the needle 104. Thismechanism can allow the needle 104 to be inserted but prevent the needle104 from being removed. The needle holder 149 can also include anelastic material that can allow a needle 104 to be pressed into thematerial but may resist the movement/removal of the needle 104. Theneedle holder 149 may also include a magnet, which can attract theneedle 104. These features can be mixed and matched or omitted in anycombination to provide an effective means for holding used needles 104.The surgeon can press the needles 104 fully into the used needle holder149 and release the needle 104. Once fully inserted the needle holder149 will not release the used needles 104. The surgeon can preferablyinsert the used needles 104 sequentially. The number of needles 104 caneasily be counted. In this example, needle receptacles 157 are arrangedin two rows of 10 receptacles 157. In other embodiments, any otherreceptacle configuration can be used and the receptacles 157 can belabeled with numbers.

FIG. 44 illustrates a top view and FIG. 45 illustrates a side view of anembodiment of a used needle holder having a tapered needle receptacle161 and a permanent magnet 163 mounted on a base 164. The needles 104are held at a proximal end with a needle driver and the surgeon canplace the tips of the used needles 104 into the side opening of the usedneedle holder. The needles 104 can be placed flat against the permanentmagnet 163. The magnet 163 can provide a raised needle holder surface sothat the proximal end can be held until the needle 104 is held flatagainst the permanent magnet 163. The surgeon can then release theneedle 104 knowing that the used needle 104 is securely in the usedneedle holder 161. The used needle holder 161 can be constructed ofclear plastic so that the number of used needles 104 in the used needleholder 161 can be seen and counted.

FIG. 46 illustrates a top view and FIG. 47 illustrates a side view ofanother embodiment of a used needle holder 165. The needle holder 165can include a housing that has an interior volume and a needle slot. Thesurgeon can align the used needle 104 with the slot 167 and insert theneedle 104 into the housing with the needle driver approximatelyperpendicular to the length of the slot 167. The surgeon can then rotatethe used needle 104 so that it is out of alignment with the slot 167 andplace the needle 104 against a permanent magnet 163 within the housing.The magnet 163 can provide a raised needle holder surface so that theproximal end can be held until the needle 104 is held flat against thepermanent magnet 163. The surgeon can then release the used needle 104and remove the needle driver. The used needle 104 will be held againstthe permanent magnet 163 and even if the needle 104 comes loose it willbe held within the needle holder 165 housing.

In an embodiment, a platform can be used by the surgeon to hold tools,sutures, needles, suture packs, sharps container, etc. The platform canbe secured to a forearm and/or hand and/or forearm and/or fingers on oneor more dorsum surfaces of the surgeon so that the objects can be easilyaccessed without the need for any interaction with anyone else such as ascrub technician. Thus, when using the platform, the surgeon does notneed to interact with anyone else. The surgeon can remove objects fromthe platform that are needed and place and store objects on the platformthat are no longer needed. The elimination of interaction betweenmultiple individuals to handle the sharp objects simplifies the surgicalprocedure and reduces the chances of cuts or other injuries such aslacerations, punctures, abrasion, break in the skin, etc.

In an embodiment with reference to FIGS. 48 and 49, the inventiveplatform 145 can have a multi-layered construction. The main structuralelement can be a structural layer 169 which can be malleable and mayalso function as a barrier. The ability to plastically deform thestructural layer 169 can allow the surgeon to easily adjust the shape ofthe platform 145 to provide any desired fit and configuration. Anexample of a suitable structural layer 169 material can be aluminum andaluminum alloys which provides a durable, lightweight, ductile andmalleable metal material. The thickness of the aluminum structural layer169 can be between about 0.01 and 0.10 inches. Any portion of thealuminum structural layer 169 can be easily bent by hand into thedesired shape resulting in plastic deformation so the structural layer169 will retain the bent shape. In other embodiments, any other materialthat has similar characteristics can be used.

In addition to providing a stable platform 145 for tools and objects,the structural layer 169 can also provide a protective barrier for thesurgeon from sharp objects. If a surgeon accidentally directs a sharpobject towards the dorsum of the forearm, the structural layer 169 ofthe platform 145 will block the sharp object and prevent any injury tothe portions of the forearm and wrist and hand covered by the platform145. Aluminum is a material that is softer than steel. Thus, a tool orsharp object that is pressed against the structural layer 169 will tendto not be scratched or otherwise damaged by the contact with the softerstructural layer 169 material.

FIG. 48 illustrates a side view of a multi-layer platform 145. A loweror inner surface of the structural layer 169 can be bonded to an innerelastic foam layer 171. When the platform 145 is attached to the forearmof the surgeon, the inner foam layer 171 can be placed on the forearmand hand dorsum of the surgeon. The inner foam layer 171 can have aporous open cell structure. Because the foam does not contain gasbubbles, it can be more compressible than closed cell foams. However,both closed and open cell foams can be used. The inner foam layer 171can provide improved comfort and conformability. The elasticity of theinner foam layer 171 allows the structural layer to be bent as describedabove. A suitable inner foam material is natural rubber latex.

As shown in FIGS. 48 and 49, the structural layer 169 can includebendable legs 175 that extend outward from the sides of the platform145. These legs 175 can be bent to wrap around the forearm of thesurgeon. The inner foam layer 171 provides a conforming fit to variableanatomy that is securely attached to the forearm. The inner foam layer171 also provides a comfortable padded surface that disperses thecompressive forces of the legs on the forearm. Because the malleablestructural layer 169 is plastically deformed to any shape, the legs ofthe platform 145 can be accurately fitted to any forearm. Because therecan be various configurations and sizes that best suit specificapplications, the size and shape of the platform 145 can be any suitabledimensions. The inventive platform is not limited to the illustratedembodiments.

With reference to FIGS. 50-53, various shape multi-layer embodiments ofthe platform 145 are illustrated. These multi-layer platforms 145include a structural layer 169 secured to an inner layer 171 and anouter layer 173. Legs 175 can extend from the platforms 145 and wraparound the surgeon's arm 143. In the illustrated embodiments, thesurface area and shape of the platform 145 over the hand portion of thearm 143 can vary dramatically. The inventive platform 145 is not limitedto the illustrated embodiments. With reference to FIG. 53, themulti-layer platform 145 with legs 175, an inner layer 171, a structurallayer 169 and an outer layer 173. The platform 145 is illustrated with atool holder for holding tools 151, suture pack holder for holding suturepacks 101 and a used needle holder 149 for holding used needles 104.

Although the inner elastic foam layer has been described as being bondedto the structural layer, there can be portions of the inner foam layerthat are not bonded to the structural layer. For example, in someembodiments, the platform can include tool holders that are located atholes formed in the structural layer. The tools such as needle driverscan be placed in the holes with the thin body of the needle driverdistal to the tool finger holes. The thin body can be placed through thehole while the handle finger holes of the needle driver cannot passthrough the hole because it is wider than the diameter of the hole.Thus, the handle will hold the tool in place and prevent it from passingcompletely through the hole. The holes can be oriented such as toproperly orient the tools for easy grasping by the contralateral hand.For example the holes may be oriented as slots with the long axisparallel or at a specific angle to the long axis of the forearm suchthat the finger loops of the needle holder can be easily grasped by thecontralateral hand without the need for contralateral forearm motion. Inan embodiment, the tools are held in the tool holders of the platformwith the structural layer between the center of gravity of the tool andthe handle or finger hole portion of the tool. As discussed, the innerand/or outer foam layers that are bonded to the structural layer canprovide friction which can prevent the movement of the tool. Thus, thetools can be held in the tool holders by a combination of gravity andfriction.

In some embodiments, the upper and lower foam material adjacent to theholes is removed. However, in other embodiments, the foam layers can beleft over the holes. For example with reference to FIG. 54, in the innerfoam of the tool holder holes, a smaller hole 177 can be formed withinan hole 179 in the barrier material. The tool can be pressed through thesmaller hole 177 and because the inner foam is elastic, the smaller hole177 can expand as the tool is pressed through the hole 177. The staticfriction of the expanded foam hole 177 circumference which is in tensionagainst the sides of the tool can prevent accidental removal of the toolfrom the platform. The foam can also act as a dampening device thatprevents the tools from knocking or sliding against the inner diameterof the hole 179 in the structural layer which can create noise andvibrations. This dampening feature can be important during delicatesurgical procedures.

It is also possible to have a smaller hole 178 (FIG. 55) or larger hole178 (FIG. 56) formed in the upper outer layer foam over the tool holes179 in the barrier layer. Again, the upper layer foam can provide afriction force that can hold the tools in the tool holes 179. In yetother embodiments with reference to FIG. 57, the upper and lower foamlayers may have smaller holes 177, 178 that are not aligned with eachother. By offsetting the alignment the foam layers can cause the toolsto be angled relative to the platform. This can provide more clearanceso the ends of the tools are not rubbing against the forearm of thesurgeon.

In other embodiments the inventive surgical platform can include anotherouter elastic foam layer that is bonded to the outer surface of thestructural layer opposite the inner surface. The outer foam layer canhave different physical properties than the inner foam layer. Asdiscussed above, the platform can be used to hold tools, sutures, suturepacks, needles, sharps containers, etc. The sharps containers caninclude various embodiments including: sponges, enclosures, magnetizedsurfaces and/or combinations of different embodiments. In an embodimentthe outer foam layer can have physical characteristics that will improvethe connection between the objects and the platform. For example, theouter surface of the outer foam layer can have a greater surface areafor better anti-slip surface that provides a high static coefficient offriction with the objects that effectively grip the contact surfaces ofthe object.

In an embodiment with reference to FIGS. 58-63, the structural layer 169can have tabs 181 that can be bent upward from the plane of thestructural layer 169. An object 108 such as a suture pack can be placedadjacent to one or more of the tabs 181 and the tabs 181 can be bentover an exposed surface of the object 108 to hold the object 108 againstan edge of the outer foam layer 173. As discussed, the malleablestructural layer 169 material may be plastically deformed and the benttabs 181 can hold the object 108 against the platform 145. Thehorizontal force of the tab 181 against the object 108 can cause acompressive force between the object 108 and the outer foam layer 173 asshown in FIG. 64.

It can be very important to hold objects 108 in a secure manner to theplatform 145. In an embodiment, the outer foam layer 173 can be a highfriction material that prevents or resists movement between the object108 and the outer layer 173. The friction force between the objects 108and the outer surface of the outer foam layer 173 can be described orquantified based upon the static coefficient of friction (COF), whichcan be symbolized by the Greek letter μ_(S). The static COF is adimensionless scalar value that describes the ratio of the force offriction between two bodies and the force pressing them together. Thecoefficient of friction depends on the materials used. For example,slippery materials such as Teflon on smooth surfaces can have a lowcoefficient of friction, while rubber on a suture package surface canhave a higher coefficient of friction. Coefficients of friction rangefrom near zero to greater than one. In an embodiment, the staticcoefficient of friction between the outer surface of the outer layer 173of foam and the object 108 coupled to the platform is greater than 0.3.The friction force is quantified by the staticfriction=μ_(S)×compression force.

The compression force can be applied by a clamp, a tab 181, elasticmaterial, a clip, a spring and/or any other suitable mechanical device.The compression force can also be provided by the foam. The compressionforce can be stored in the foam material by manually bending the tab 181over and onto the suture packet. The compressed foam will try to expandand this foam expansion force can help to hold the suture packet inplace. The compression force can prevent any vertical movement of thesuture packet and the friction force can prevent any horizontal movementrelative to the platform surface. In an embodiment, the compressionmechanism is attached to the platform and applies a force to compressthe object against the outer foam layer. The compressive force resultsin a friction force that prevents a sliding movement of the object overthe surface of the outer foam layer.

With reference to FIG. 49, in an embodiment, the outer foam material 173can provide a functional structure. For example, after needles are usedthey must be stored and accounted for. In an embodiment, a portion suchas the used suture needle region 192 of the outer foam 173 can be markedwith individual needle regions. Each of the individual needle regionscan be marked with a number 259 and adjacent needle regions can bemarked with sequential numbers 259. As the needles 103 are used, thesurgeon can place the used needles 104 in the used needle region 192. Afirst used needle 104 can be placed in a region marked 1, a second usedneedle 104 can be placed in a region marked 2, etc. The outer foam 173can be made of a thick material that allows the needles 104 to besecurely captured until the surgical procedure is completed. Because theneedles 104 are placed in numbered 259 regions, it is easy to visuallyaccount for all needles 104 used during the surgery by simply looking atthe numbers 259 in the used needle regions 192.

The described sharps container 255 can provide various benefits to theusers. The sharps container 255 is easily accessed and secured to anyportion of the platform 145 over the forearm and hand. The used needles104 are highly visible in the repository for easy used needle 104counting. The demarcations can assist in the counting of the usedneedles 104. The foam 173 in the sharps container securely holds thetips of the needles 104. The tips are also adjacent to the structurallayer 169 and cannot cause damage even if the needles 104 areaccidentally contacted or pressed further into the foam 173. The usedneedles 104 can be secured, treated and maintained in control of thesurgeon until a “group transfer” occurs. More specifically, the usedneedles 104 are secured to the sharps container 255. The used needles104 can also be treated by mechanically cleaning the distal portions andchemically disinfected. The securing of the used needles 104 can be inconstant contact and can be maintained in control of the surgeon until a“group transfer” occurs. The “group transfer” can include the transferof a group of surgical tools from the surgeon to the scrub tech. Thesurgical tools in the group transfer can include: the needle driver, theforceps, the used sharps container, the sharps container and otherobjects.

In an embodiment, outer foam layer 173 can include different areas thathave different physical properties. For example, first area may bedesigned to support suture packs 101 and a second area may be designedto function as a sharps container 255 as described above. The first areathat supports the suture packs 101 can be made of a thinner less elasticfoam material with a higher COF exposed surface than the second area.The suture packs 101 can be compressed against the first area and thehigh COF can prevent movement of the suture packs. This feature can beimportant because the surgeon must manually place the proximal ends ofthe needles 103 in needle driver. Any unwanted movement of the needles103 can make this task more difficult.

With reference to FIGS. 58-59 in an embodiment, the structural layer canhave one or more tabs 181 that can be used to secure objects to theplatform 145. The outer foam layer 173 can be removed from thestructural layer 169 which can be exposed. Bendable tabs 181 can beformed in a suture pack carrier 183 area of the exposed structural layer169. These bendable tabs 181 can be cut in the structural layer 169 andcan remain planar with the structural layer 169 before being used. Thetabs 181 can be arranged in a staggered manner so that objects such assuture packs can be secured to the suture pack carrier 183 area of thestructural layer 169 with the tabs 181 that most closely fit theobjects.

FIG. 58 illustrates a suture pack carrier 183 before suture packs 101are secured and FIG. 59 illustrates a suture pack carrier 183 aftersuture packs 101 have been secured. For example, a suture pack or suturepacks 101 may be substantially planar rectangular structures that areheld to the platform with the tabs 181. The suture packs 101 can beplaced on the platform 145 and the tabs 181 can be bent up and over onemore side edges of the suture packs 101. The suture packs 101 can comein various different sizes. Thus, the suture pack carrier 183 on theplatform 145 can have multiple tabs 181 can be set in differentlocations to accommodate the variety of suture pack 101 sizes.

With reference to FIGS. 60-63 in other embodiments, multiple suturepackets 101 can be stacked over the same suture packet carrier 183. FIG.60 illustrates a suture pack carrier 183 before suture packs 101 aresecured and FIG. 61 illustrates a suture pack carrier 183 after multiplelayers of suture packs 101 have been secured. FIG. 62-63 illustrate asuture pack carrier 183 after multiple layers of suture packs 101 havebeen secured and some suture packs 101 have been removed. Different tabs181 can be used to hold each of the layered suture packets 101. Afterall needles 103 of a suture packet are removed, the suture packet 101can be removed to expose the underlying suture packet 101. In apreferred embodiment, the surgeon can grasp a side of upper depletedsuture packet 101 with the needle driver and remove it from the suturepacket carrier 183. The underlying suture packet 101 will then beexposed and the needles 103 will be accessible to the surgeon. Thisprocess can be repeated until the bottom suture packet 101 is exposedand all necessary needles 103 are used by the surgeon.

In the illustrated embodiment, the tabs 181 hold one or more of thesuture packs 101 to the platform 145. Some of the tabs 181 are orientedto be substantially perpendicular to the edges of the suture packets 101while other tabs 181 can be oriented at various other angles. In theillustrations, the tabs 181 on the lower right are oriented to be about45 degrees to the side edges of the suture packets 101.

In an embodiment, the multi-layer platform can have a suture packcarrier. FIGS. 64-67 illustrates side views of various suture packcarriers 183. With reference to FIG. 64, the upper foam layer 173 can bepartially removed from some areas of the platform which can expose thestructural layer 169. The objects, such as a suture pack 101, can bepressed against the edges of the upper foam layer 173. This force on theobject can compress the object into side of the upper layer foam 173.The compression force creates a friction force that can hold the edge ofthe object to the platform adjacent to the structural layer 169. One ormore sides of the object can be compressed into different surfaces ofthe upper foam layer 173. One or more tabs 181 can be secured over thesides of the object opposite the side of the object pressed into theupper layer foam 173.

In the illustrated embodiments, the suture pack retaining structures canadapt to wide range of suture pack 101 sizes. Suture packs 101 can varyin size from about 1″×3″ to about 3″×4″. The suture packs 101 can have a“flat” conformation. The tabs 181 can provide an easy and secure systemfor attaching or locking the suture packs 101 onto the barrier platform.The platform can accommodate multiple suture packs 101 and the packs canalso be easily removed from the platform.

With reference to FIG. 65, in an embodiment, the tabs 181 can extendthrough the upper foam layer 173. The suture pack 101 can be placedbetween the tabs 181 and the ends are bent over the edges of the suturepack 101 to hold it against the upper foam layer 173. With reference toFIG. 66, in an embodiment, the upper foam layer 173 can be partiallyremoved. Tabs 181 can be wrapped over the edges of the suture pack 101to hold it against the structural layer 169.

With reference to FIG. 67, in yet another embodiment, holes that areslightly smaller than the perimeter shape of the suture packs 101 areformed in the upper foam layer 173. The suture packs 101 can be pressedinto the holes until they are against the structural layer 169 or thelower surface of the hole. The compression of the suture packs 101 maycause them to bow upward. In order to prevent this motion, fasteners 185can be placed in a center portion of the suture pack 101 to hold it inplace. In other embodiments, where the suture pack 101 is made of astronger material that does not deform under compression, the fastener185 may not be necessary.

The inventive platform has been described with various systemcomponents: tool holders, tools, suture pack holders, suture packs,armed needles, used and sharps containers, all mounted on a platform.Although these components can be set at predetermined locations on theplatform, in other embodiments, the inventive system can have a modularconfiguration. In these embodiments, the system components: toolholders, tools, suture pack holders, suture packs, armed needles 103,sharps container can be independent and modular. The user can mix andcombine these individual components and place them in any desiredpositions on the apparatus and platform. The individual components canhave various connection mechanisms such as: hook and loop (Velcro),snaps, tack features, screw fasteners, tabs, or any other suitableconnection mechanisms such as elastic bands and adhesives. Once thesurgical procedures are completed, the system components can be removedfrom the inventive platform. It may be possible to clean and sterilizethe platform, attach new modular components and reuse the platform.

The present platform invention can address several operating room issuesincluding improved safety and efficiency. As discussed, the structurallayer of the platform can create a barrier that prevents needle sticksto forearm and dorsum of hand. Thus, both the surgeon's hand and forearmcan be protected. The platform can be held against the forearm but canbe spaced away from the hand, which may allow for full movement of thesurgeon's (wrist, hand, fingers) hand. The platform also does notinterfere with the elbow range of motion.

The inventive platform system provides various benefits. The bendablelegs allow the platform to adapt readily and securely to variableforearm sizes. The platform allows the surgical tools and needles to beoriented in any desired position. Ideally, the system can minimizeunnecessary forearm motion. The suture pack(s) can be placed on anyportion of the platform including the radial border of forearm and thevolar forearm. The platform provides a protective barrier to the handand forearm while still allowing full hand range of motion. The angle ofthe hand cover portion of the platform relative to forearm portion canbe about 10-45 degrees. However, the hand element can be flexible andthe angle and shape of the hand element can be adjusted to any desiredshape. The inflection point may be: a living hinge, a mechanical hingeor any other suitable articulation movement mechanism.

For example, with reference to FIGS. 88 and 89, a multi-layer platformis illustrated that includes a movable inflection point 207. When thehand is in a straight position, the platform can assume a normal shape.However, then the hand is moved up relative to the forearm, the hand cancontact the bottom of the portion of the platform and the hand portion146 of the platform can rotate with the hand as shown in FIG. 89.

In preferred embodiments, the sharps container can be physicallyadjacent to or in close proximity with the suture packet holder and thesuture packets. The sharps container and the suture packets can be onthe same support structure such as a platform. This configurationfacilitates improved surgical work flow and condenses several complexcoordinated motions into more streamlined simplified actions performedby the surgeon. As discussed, the platform with the suture packetholders secured to suture packets and the sharps container can be on thesame platform apparatus mounted on a non-dominant arm of the surgeon.When a suture is required, the surgeon can grasp an armed needle havingan attached suture from the suture packet and use the suture on thepatient. When the stitch is completed, the surgeon can then place theused needle in the sharps container and then easily grasp a new armedneedle from the suture packet.

Various sharps container designs can combine with the inventive system.In an embodiment, the sharps container can be a soft open or closed cellelastic material such as foam or a sponge which can be marked with asequence of numbered regions. The used needles can be inserted into thesoft cell material which will hold the used needles in place. In anembodiment, the sharps container cell material can be adjacent or bondedto one or more layers of a thin elastic homogeneous material such as asoft plastic or rubber that can be easily pierced by the used needleswithout substantially deforming the soft elastic cell material. Thehomogeneous material can provide a friction force that can increase theresistance to inserted needle movement that can further prevent theaccidental removal of the used needles from the sharps container. It canalso be easier to print the number markings on a solid rubber materialthan on a soft elastic cell material such as foam.

A potential problem with used needles is their ability to transmitviruses when a used needle accidentally breaks the skin on an operatingroom surgical member. However, if the used needle is cleaned and/ordisinfected the used needles are much less likely to spread viruses. Inyet another embodiment, the soft open or closed cell elastic materialcan be coated and/or saturated with a disinfectant such as bleach orother antimicrobial materials. The disinfectants can be in the form of ahigh viscosity gel that can be held within the foam material but willnot easily be removed from the elastic cell material. In an embodiment,a portion or all of the soft open or closed cell elastic material of asharps container can be surrounded by a layer(s) of the thin elastichomogeneous material in order to help retain a disinfectant liquidwithin the soft cell sharps container material (may need to elaborate,clarify).

With reference to FIGS. 102, 103 the inventive system can clean anddisinfect the used needles 104 as they are inserted into the soft openor closed cell elastic material 251, 253. As the used needles 104 piercethe soft cell material 251, 253 and/or the solid elastic materiallayer(s) 250, 252, that can be cleaned by wiping the outer surfacesagainst these materials. The used needles 104 can be disinfected whenthey are exposed to the disinfectant. Thus, if any of the used needles104 are accidentally removed from the described sharps container 255,they are cleaned and disinfected and are much less likely to spreadviruses.

With reference to FIGS. 96-99 in other embodiments, the sharps container235 can include an enclosure having a door mechanism 237 that is openedto received used needles and closed to prevent used needles from exitingthe sharps container 235. Different mechanisms can be used to controlthe position of the door 237. For example, in an embodiment, theposition of the door 237 can be manually controlled with a switchmechanism. The door control mechanism can be coupled to a spring 245which can hold the door 237 in the closed position and a manual actuatorsuch as a lever 243. When user presses against the lever 243, the spring245 can be compressed and the door(s) 237 can be open. The user can dropthe used needles into the repository and the release the lever 243 toclose the door 237.

In the illustrated embodiment, the door 237 mechanism is coupled to apair of rotational members 246 on opposite sides of the sharps container235. A lever 243 can extend away from the receptacle housing. When noforce is applied to the lever 243, a torsional spring 245 or any othersuitable spring mechanism can exert a counter clockwise torque about oneor both of the rotational members 246. This torque can hold the door 237in the closed position against a stop 247. When a downward force isapplied to the lever 243, a clockwise torsional force can be applied tothe door 237 mechanism that is greater than the counter clockwise spring245 force. The door 237 mechanism can rotate clockwise and open to allowused needles 104 to be deposited in the receptacle 235. Once the usedneedle 104 is captured, the use can release the lever 243 and the door237 can return to the closed position against the stop 247.

The manually controlled door configuration can allow the user tocarefully control the door 237 to prevent used needles from escaping thesharps container 235. The repository housing can include an opening atthe top surface and the door 237 mechanism can be mounted on tworotational members 246 on opposite sides of the housing that define arotational axis. The doors 237 can be above the rotational axis 246 anda spring 245 can normally hold the door 237 in a closed position againsta rotational stop 247. The lever 243 can be coupled to the door 237mechanism and exit a side of the housing that is easily accessible tothe user such as the side of the housing closest to the user. Actuatingthe lever 243 can cause the door 237 mechanism to rotate about therotational axis and open. When the lever 243 is released, the spring 245will rotate the door 237 mechanism back to the closed position.

With reference to FIGS. 100 and 101 in an embodiment, the door 237 canbe coupled to an automatic control system 249 which includes anaccelerometer(s), a processor, a power supply and an actuator. Theaccelerometer(s) can detect the orientation of the needle receptacle 235based upon the gravitational forces. When the accelerometers detect thatthe needle receptacle 235 is substantially upright in position, theprocessor can control the actuator to open the door 237 and when theneedle receptacle is not properly oriented, the processor control theactuator to close the door 237. In an embodiment, the system can beprogrammed or set to open the door 237 at a specific range oforientations that can correspond to the optimum limb or tool positionswhich can allow for the needle to be dropped into the receptacle 235.The system can also detect abnormal situations which can indicate anaccident. For example, if the detected acceleration is significantlygreater than the gravitational force, the system can interpret this asan accidental impact with the sharps container and the processor cancontrol the actuator to close the door 237.

Alternatively the position of the door can be automatically controlledby gravity. When the sharps container is used on a forearm-mountedplatform, the door can be at the top of the repository and open when therepository is in an upright position. However, when the sharps containeris rotated, the doors can close to prevent used needles from exiting.

FIGS. 92-95 in an embodiment, the repository housing 235 can include anopening at the top surface. The door 237 mechanism can be mounted on tworotational members 246 on opposite sides of the repository housing 235that define a rotational axis. The doors 237 can be above the rotationalaxis and a counter weight(s) 239 below the rotational axis. The door 237mechanism can open when the repository housing 235 is upright relativeto the rotational axis within a range of about 0 to 30 degrees. Atrotational positions greater than 30 degrees or more away from verticalalignment, the doors 237 can close to prevent used needles 104 fromescaping the repository 235. In use, the repository 235 can bevertically oriented relative to the rotational axis to open the door andthe used needle 104 can be dropped in the repository 235 through theopen door 237. The surgeon can then rotate the forearm out of verticalalignment to close the door 237 and grasp a new needle from the suturepacket. The process can be repeated after the needle is used.

Because the suture packets and the sharps container are in closeproximity, the surgeon's movement of releasing a used needle 104 andpicking up a new needle is simple and short. Thus, this configurationhas micro-ergonomic benefits over other suture packet and sharpscontainer methods. As discussed above, the sharps container can be anelastic foam or other material into which used needles 104 are insertedwith the sharp points directed towards a structural layer which blocksthe needle from further movement and protects the surgeon's forearm fromthe used needle. It has also been found that mounting the used needle104 on the dorsum on the forearm can also resist injury to the surgeonfrom the exposed suture ends of the needles. The dorsum of the forearmcan rotate with the hand. However, the forearm is not easily moved intoa position where the dorsum of the forearm faces the body. The forearmis inherently configured with the volar and palmar surfaces facing thebody while the dorsum faces away from the body. This human anatomylimitation provides another safety feature for the inventive forearmmounted platform with sharps container.

With reference to FIGS. 68-71 in an embodiment, the platform apparatusmay include a platform 187 on the dorsum of the forearm onto which asharps container is mounted and suture packet holders 183 mounted on asurface or platform 189 of the apparatus on the volar side of theforearm 143. In this configuration, the surgeon can supinate thenon-dominant assisting limb to rotate the suture packet mounted on thevolar side into any desired orientation before grasping a new armedneedle. As discussed, the human anatomy allows for a wider range ofnatural movement when the volar side of the forearm 143 is facing thebody. Thus, the surgeon can more easily and precisely move the needle tothe desired position before grasping the new needle with the needleholder. The needles are securely attached to the suture packs 101 andrequire a physical force to be removed. Gravity will not cause theneedles to come loose from the suture packs 101 and the placement of thesuture packs 101 below the forearm 143 will not cause new armed needlesto be accidentally released. In contrast, it may not be desirable tomount the tool holders and sharps container on the volar side of thelimb.

With the used sharps container on a dorsal side and suture packs 101 onthe volar side, the movement and micro-ergonomics are slightly differentbecause the surgeon will rotate the forearm 143 after the used needle isplaced in the sharps container and while the new armed needle is beinggrasped. However, because the suture packet 101 and sharps container arestill in close proximity, for example within less than 7 inches, themovement of the surgeon is still very efficient. This configuration alsohas the benefit of a safe used needle 104 position and a more adjustablesuture packet 101 position.

The described process used with a medical apparatus on a forearm of auser can be illustrated with reference to flow chart shown in FIG. 90. Amedical apparatus can have a platform on a dorsal side of the forearmand a volar platform on the volar side of the forearm. A used needlerepository can be attached to the dorsal platform on the dorsal side ofthe medical apparatus and a suture pack holder can be attached to thevolar side of the medical apparatus 209. A suture pack can be placed inthe suture pack holder and the medical apparatus can be worn on a firstarm of a user who can be surgeon, which can be the non-dominant arm 211.The user can move the first arm to adjust the position of the suturepack and the user can grasp a suture needle with a needle driver held bythe second arm of the user which can be the dominant arm 213. The usercan then remove the suture needle from the suture pack and use theneedle to install a suture on a patient 214. Once the suture isinstalled and possibly knotted, the user can move the used needle lessthan one foot from the suture insertion point on the patient and placethe used needle in the sharps container by the surgeon only 215. Thesurgeon can determine if additional sutures are needed 217. If moresutures are needed, the steps 213, 214 and 215 can be repeated until allsutures have been installed on the patient. Once no more sutures areneeded this process is done 219. As discussed, the benefit of thisprocess is that only the surgeon handles the sutures and needles and themovement of the needle can be, for example, within one foot from thesuture insertion point which can improve efficiency and prevent injuryfrom sharps.

The sutures and needles can remain within the near surgical field duringthe installation of the sutures.

In yet another embodiment, the suture packet holder (with a suturepacket) and a sharps container can be mounted on a surgical tool on thesame plane, facing the same direction, or on opposite planes. The suturepacket holder and the sharps container can be held by the surgeon'snon-dominant hand. In the illustrated examples shown in FIGS. 81 and 83the suture packet 101 and the sharps container 191 can be mounted onopposite sides of a surgical tool 201 such as forceps. When the suturepacket holder 183 and the sharps container 191 are mounted opposite eachother, the surgeon can rotate the suture packet 101 toward the needledriver so a new armed needle can be grasped. When the suture has beeninstalled, surgeon can rotate the tool between about 90-270 degrees sothe sharps container 191 faces the used needle and the surgeon candeposit the used needle in the sharps container 191. The surgical toolcan be rotated between about 90-270 degrees back to its originalposition so a new armed needle can be grasped and the process can berepeated. In other embodiments, the suture packets and sharps containercan also all be on same plane, facing the same direction with the unusedand used needles side by side.

An embodiment of this process can be illustrated with reference to theflow chart shown in FIG. 91. A medical apparatus such as forceps canhave a used needle repository on a first side of a proximal end portionand a suture pack holder on an opposite side can be provided to a userwho can be surgeon 221. A suture pack can be placed in the suture packholder and the medical apparatus can be held with a first hand of theuser 223. The user can adjust the position of the suture pack bymovement of the first hand and the user can grasp a needle with a needledriver held by the second hand of the user 225. The user can then removea needle from the suture pack and used the needle to install a suture ona patient 227. Once the suture has been installed, the user can rotatethe medical apparatus so that the needle repository faces the secondhand and the used needle moves less than a foot to place the needle inthe used needle repository which can be a sharps container by thesurgeon only 229. If more sutures are needed, the steps 225, 227 and 228can be repeated until all sutures have been installed on the patient.When no more sutures are needed this process is done 233. Again, thisprocess can be performed by only the surgeon and the needles may moveless than one foot from the incision which can improve efficiency andprevent injury from sharps.

In other embodiments, various types of sharps containers can be used tohold used needles. For example with reference to FIG. 150, the sharpscontainer 255 can have a door 237 that is coupled to a lever 243. Whenthe lever 243 is actuated, the door 237 can open to allow a used needleto be inserted into the sharps container 255. When the lever 237 isreleased, the door 237 can close to prevent the used needles fromescaping. In an illustrated embodiment, the user can simultaneously holdthe forceps 201 and actuate the lever 243 to open/close the door 237 tothe sharps container 255. For example, the user can hold and actuate theforceps 201 between the thumb and long finger. The index finger canindependently contact and actuate the lever 243 to open the door 237.The index finger can also allow the user to apply additional downwardforce to the forceps 201 if necessary.

With reference to FIGS. 77 and 78, in the illustrated embodiment, thesuture pack 101 and sharps container 191 are coupled to each other alonga top side and two vertical sides to form a needle receptacle and suturepack assembly 205. The bottom edge can be open so that the structureforms a tool attachment pocket 204. The inner sides of the suture packand sharps container can be coated or attached to an adhesive layer 203that is covered with a release paper 202 prior to installation on atool. The user can squeeze the two vertical sides of the suture pack 101and sharps container assembly as shown in FIG. 77 to open the pocketshown in FIG. 78. The user can then remove the release paper 202 toexpose the adhesive 203 as shown in FIG. 79. A tool 201 such as aproximal end of forceps can be inserted into the pocket 204 against theadhesive surfaces 203 as shown in FIG. 80. The suture pack 101 andsharps container assembly 191 can be pressed together to secure thedevice to the end of the tool 201 as shown in FIG. 81. Because theinventive structure is being attached to a surgical instrument 201, itcan be important to use lightweight materials so that the feel andbalance of the tool is not significantly reduced when the system isused. In many embodiments, the weight of the structure is less than0.100 lbs or 45 grams.

With reference to FIGS. 82-84 various view of a needle receptacle andsuture pack assembly 204 mounted on a surgical tool 201 are illustrated.FIG. 82 illustrates a front view of the needle receptacle and suturepack assembly 205 with the suture holder 183 with a plurality of suturepacks 101 holding suture needles 103 is illustrated. The suture packs101 can be held to the suture holder 183 with tabs 181. With referenceto FIG. 83, a side view of the needle receptacle and suture packassembly 205 is illustrated with the suture packs 101 on a front sideand the used needle receptacle 191 on the opposite side. With referenceto FIG. 84, a back view of the needle receptacle and suture packassembly 205 with used needles 104 placed in the needle receptacle 191.

In an alternative embodiment, the back surfaces of the suture packetscan be attached to a foam needle repository and the opposite side of theneedle repository can be attached to the tool. In yet another embodimentof a needle receptacle and suture pack assembly 205 as shown in FIGS.85-87, the tool 201 can be attached to one or between two foam needlerepositories 191 that are sandwiched between two suture pack holders183. In this embodiment, the used needles 104 are inserted into theexposed sides of the foam needle repository 191. This provides a muchdeeper used needle 104 insertion because the foam extends across theentire width of the structure rather than the thickness. In theillustrated embodiment, the needle areas can be marked with a sequenceof numbers so that the used needle 104 count can be easily performed.FIG. 85 illustrates a front view of the needle receptacle and suturepack assembly 205 facing one of the suture pack holders 183. FIG. 86illustrates a side view of the needle receptacle and suture packassembly 205 facing one of the foam needle repositories 191 and FIG. 87illustrates a back view facing the second suture pack holder 183.

With reference to FIGS. 72-76, in other embodiments, a platform 145 withsuture packet holders 183 that can include tabs 181 for holding suturepackets 101 and a sharps container 191 can be mounted on a mechanicalarm at a fixed or movable location in the surgical field. For example,the platform 145 can be a separate structure mounted to an arm having anadjustable joint 193 as shown in FIG. 73 or a flexible arm 195 that canbe moved to any desired position as shown in FIG. 74. The base of thearms 193, 195 can be clamped to a fixed surface 197 such as a table.

In other embodiments a solid platform is secured to the surgical drapeon the fringe of the surgical incision. In an embodiment the device ismounted opposite the surgeon if the surgeon has no assistance or on theadjacent side to the surgeon's dominant hand. In an embodimentillustrated in FIGS. 75 and 76, the platform 145 with suture packetholders holding suture packets 101 and a sharps container can be mountedon an “A” frame structure 199 that allows the angle of the platform 145surface to be adjusted. For example, the platform 145 can mount thesuture packets 101 and suture repository 191 at an angle to the surfaceof about 0-50 degrees that most easily facilitates the grasping of thenew armed needles and used needle deposition motions. The platformstructure 199 can be attached to the surgical drape with staples ortape. A platform 145 with the suture packet(s) 101 and sharps container191 adjacent to the needle holder securely mounted to the within thesurgical field will facilitate the improved and more efficient surgicalworkflow. In this embodiment as illustrated in FIG. 72, the proximity ofthe suture packet holders holding suture packets 101 and a sharpscontainer 191 can be within about 4 inches.

A common feature among the inventive devices described above is thatthey combine armed and/or unarmed needle and/or suture pack(s) with aused needle retention device on the same structure. The armed and/orunarmed needle and/or suture pack(s) with a used needle retention devicecan be fixed to the structure permanently and/or in frangibleassociation. This configuration allows for improved micro-ergonomics.The surgeon can hold a needle driver in one hand and another tool suchas forceps in the second hand. The surgeon does not have to let go ofthe needle driver or the forceps when needles are removed from thesuture packs or when the used needles are placed in the used needleretention device. Since the surgeon does not have to remove the fingersfrom the instruments, the procedures can be a more efficient and safersince there is much less likelihood of accidentally dropping aninstrument.

The use of the forearm for needles and used retained needles can provideimproved efficiency, safety, and better micro-ergonomics. Using such asystem, the surgeon always knows where used needles are located. It isalso is very difficult to accidentally jab the surgeon's body with theused needles unless the surgeon crosses forearms to appose the dorsum ofnon-dominant forearm to another part of your body. If used needles areon the surgical field it is much easier for the surgeon's hand toaccidentally be placed on them. Having the new and used needles on thein close proximity allows for apposition. The installation of sutures ina patient is done with a circular motion by the surgeon. The surgeon canmore easily, drop a used needle off in the sharps container and grab thenext new needle.

As illustrated in the top view of an embodiment of the inventiveplatform shown in FIG. 49, the system can include tool holders 177,suture pack holders 183 and a sharps container 191. In an embodiment,one of the tools stored in the tool holder 177 can be a bulb irrigator,which can be a hollow container that stores saline for irrigation of thesurgical wound. The surgeon can point the nozzle of the bulb irrigatorat the wound and squeeze the bulb portion to control the flow anddirection of the saline. By storing the bulb irrigator on the platform145, the surgeon can access this tool at any time. The scrub tech who isobserving the surgery can assess, and thereby anticipate that the nextstep might be: bone wax or gelfoam application (as required duringcertain procedures, such as lumbar decompression) or cottonoid in thatstepwise function. For example, the surgeon can reach for the bulbirrigator, perform the irrigation and upon placing it back on theplatform 145 the scrub tech can know to be ready with the next step.Since the surgeon is handling the bulb irrigator, the surgeon will knowhow much saline is left in the bulb. The surgeon can feel and see thequantity of saline in the bulb irrigator and ask for more saline when arefill is needed. Alternatively, the scrub tech can spend more timewatching the surgeon and less time passing objects to the surgeon. Bywatching the surgeon handle the bulb irrigator, the scrub tech can seewhen the fluid level is running low and anticipate the need for moresaline. Because the actions of the surgeon and scrub tech are moreindependent, all parties can be more focused on the surgery andcommunications can be improved. These same benefits would apply to theneedle handling processes of the inventive system described above.

In some of the illustrated embodiments, the used needles are insertedinto a foam sharps container coupled to a planar mounting surface suchas a platform with the lengths of the needle approximately perpendicularto the mounting surface as shown in FIGS. 102 and 103. In otherembodiments with reference to FIG. 104, the sharps container 257 can beoriented so that the used needles 104 are inserted into sides of thesharps container 257 so that the needles 104 are more parallel to themounting surface. In an embodiment, sides of a container 257 structurecan surround the foam, except for the used needle insertion side of thecontainer 257. The container 257 can be made of a clear material andmarked with numberings 259 for needle counting. The container 257 canprevent the sharp tips of the needle 104 from exiting the sharpscontainer 257 and the increased insertion depth prevents the needlesfrom escaping. Both of these features increase the safety of the device.

In other embodiments, suture packs 101 can be placed on the uppersurface of the sharps container 257. With reference to FIG. 105 a sideview of the sharps container 257 with suture packs 101 mounted on afront surface are illustrated. FIG. 106 illustrates a front view of thesuture packs 101 holding sutures 103 mounted on the sharps container257.

In an embodiment with reference to FIG. 107, multiple layers of needlerepositories 257 can be stacked together with the inner repository 257attached to a mounting surface which can be on a protective platform ora tool. The opposite exposed side of the sharps container can be used tomount one or more stacked suture packets 101 that can be held togetherwith an adhesive. Needles can be removed from the outermost suturepacket and the used needle 104 can be inserted into the side of thesharps container 257. The used needles 104 can be inserted into the sideof the sharps container 257 into a foam material 263 that can be markedwith numberings 259 for needle counting. When the suture packet 101 isout of needles it can be removed to expose an underlying suture packet101. Because the suture packets 101 and sharps container 257 are in veryclose proximity, the micro-ergonomics of the surgical procedure areimproved.

In an embodiment with reference to FIGS. 108-110, the sharps container257 can include a material that the used needles 104 are inserted into asingle piece needle holding material through multiple surfaces. In theillustrated example, a foam material 263 can be placed within acontainer structure 257 which includes a plurality of elongated openings364 and numerical markings 258. The used needles 104 can be insertedinto an exposed top surface as well as a side surface. The used needles104 inserted through the top surface can be oriented at a shallowdiagonal angle relative to the mounting surface and the used needles 104inserted through the side surface can be more parallel to the mountingsurface. In another embodiment with reference to FIGS. 111-113, dividers261 can be placed in the container structure 257 which separate theadjacent needle holding material pieces. In this embodiment, each usedneedle 104 is inserted into a specific used needle passageway which canhelp to improve needle count accuracy.

With reference to FIGS. 114-116 in other embodiments, the sharpscontainer 257 can be configured with access only through the sidesurfaces with multiple layers so that the used needles 104 are placed inmultiple planes and mounted between one or more stacked suture packets101 and a mounting surface. The assembly components can be held togetherwith an adhesive and the assembly can be attached to the mountingsurface with an adhesive. The mounting surface can be a tool surface ora platform surface. The new needles 103 can be removed from theoutermost suture packet 101. When all needles 103 are removed from theoutermost suture packet 101, the user can peel away the depleted suturepacket 101 to exposed a full underlying suture packet 101.

In other embodiments, the suture packet 101 and used needle receptacle257 can be configured in a diagonal manner like layered shingles. In theillustrated example shown in FIGS. 117-119, a plurality of suturepackets 101 are stacked on a left side of the assembly 205. Needles 103are removed, used and then placed in the needle receptacle 257. Thesuture packets 101 can be held in place with an adhesive and when theneedles 103 are depleted, the outermost suture packet 101 can be peeledaway and discarded to expose the next suture packet 101. The used needlereceptacle 257 can have a single piece foam structure or multiple foam263 pieces which can have a plurality of diagonally oriented dividers261 separating the multiple foam 263 pieces. The dividers 261 can directthe needles 104 in a diagonal direction relative to the lower mountingsurface. This diagonal configuration increases the insertion depth andallows the user to view the insertion points on an upper surface of theassembly 205. The exposed surfaces of the sharps container 257 can benumbered 259. In addition to the upper surface insertion points, theused needles 104 can also be inserted into one or more layers through aside surface. In an alternative embodiment shown in FIGS. 120-122, thedividers 261 between the different layers of the sharps container 257can be curved so that they can be similar to the curvature of the usedneedles 104. This can improve the used needle insertion since the usedneedles 104 can follow the curvature of the dividers 257 and are lesslikely to collide with the dividers 257.

With reference to FIGS. 123-125, as discussed potential safety problemwith used needles 104 is their ability to transmit viruses when a usedneedle 104 accidentally breaks the skin on an operating room surgicalmember. If the used needle 104 is cleaned and/or disinfected the usedneedles 104 are much less likely to spread viruses. In an embodimentwith reference to FIGS. 123-140, the used needle receptacle 257 caninclude a disinfectant fluid container 264 encapsulated within a portionof the sharps container 255. The disinfectant fluid can be a liquid,gel, powder or any other suitable antimicrobial material 266. Theportion of the sharps container 255 used to contain the antimicrobialmaterial 266 can be a clear plastic and other transparent material. Anelastic material 251 can be attached to the portion of the disinfectantfluid container 264 that can seal the antimicrobial material 266 in thedisinfectant fluid container 264 portion of the sharps container 255.The elastic material 251 can be foam, rubber, plastic or any othersuitable material that can be punctured by the used needles 104.

When a needle 104 is placed in the sharps container 255, the surgeon candrive the sharp tip of the needle 104 through the elastic material 251.The needle 104 can be covered with body fluids and may be contaminatedwith bacteria and/or viruses. The used needle 104 tip can pass throughthe elastic material 251 and into the antimicrobial material 266 in thecontainer 264 portion. Since the container material can be transparent,the user to see the used needle 104 tips in the antimicrobial material266. The elastic material 251 may create a tight seal around theperimeter of the used needle 104 which can prevent the antimicrobialliquid 266 from escaping from the fluid container 264 portion of theneedle receptacle 257.

The portions of the used needles 104 that are inserted into theantimicrobial material 266 are cleaned and disinfected. Thus, these usedneedles 104 are properly treated by the act of inserting the usedneedles 104 into the receptacle 257. These disinfected treated needles104 pose much less of a threat of transferring an infection or diseasein the event of subsequent human contact. If the used needle 104 isaccidentally removed from the used needle receptacle 257, the surface ofthe needle 104 will slide against the elastic material 251 which willfurther clean the needle 104 as it is removed from the needle receptacle257 further reducing the risk of spreading an infection or diseasecompared to untreated used needles 104.

After sutures are used to close a patient, the surgical team mustperform a needle count to insure that none of the used needles 104 arein the patient. In an embodiment the used needle receptacle 257 can havea sequential series of number markings 259. The numeric markings 259 canbe on the elastic material 251 or on any other suitable portions of thereceptacle 257. The surgeon can place the used needles 104 in thenumbered spaces in the marked sequence. During the needle count, thecounter can easily perform the count by looking at the last numberedarea of each receptacle 257 having an inserted used needle 104.

The used needles 104 should be placed as far as possible into the usedneedle receptacle 257. However, the proximal end will normally beexposed after the used needle 104 is inserted into the receptacle 257.These proximal ends are not as sharp as the distal ends but can still besharp enough to cause injury to people. With reference to FIGS. 126-128,In order to reduce the risk of injury, the used needle receptacle caninclude barriers 261 that are adjacent to the can extend outward fromthe elastic material 251. The barriers 261 can create channels that cansurround the proximal ends of the needles 104 inserted into thereceptacle 257. The channels can be open on two sides and the widths ofthe channels can be wide enough for the needle driver to easily insertthe used needle 104 through the elastic material 251. These channels canalso prevent injury to the surgical staff. Even if the used needlereceptacle 257 is pressed against a body, walls of the channels canprevent the exposed proximal ends of the needles 104 from causinginjury. If the proximal end of the used needle 104 extends past theouter edge of the channels, physical contact with a proximal end willtend to safely push the needle 104 deeper into the elastic material 251and move the proximal end into channels.

The suture needles 104 are generally curved in shape. Thus, it may beeasier to insert the used needles 104 into the used needle receptacle ifthe channels are also curved or angled as shown in FIGS. 129-136. Inthese configurations, the surgeon can insert the used needles 104 withthe convex curvature side of the needle facing the concave or inwardcurvature of the channel walls. When the used needle 104 is fullyinserted, the ends of the used needle 104 can be aligned rather thanbeing offset. Different users may prefer different channel angles orcurvatures. For example, a right handed surgeon may prefer channels thathave top ends that are angled to the left as shown in FIGS. 129 and 130or curved to the left as shown in FIGS. 133 and 134. In contrast, lefthanded surgeons may prefer channels that have top ends that are angledto the right as shown in FIGS. 131 and 132 or curved to the right asshown in FIGS. 135 and 136.

In some embodiments, multiple used needle sharps containers can be usedtogether to hold a greater number of used needles 104. In an embodimentshown in FIGS. 137 and 138, the used needle sharps containers 255 can bearranged in an overlapping configuration with the channel portions ofeach of the sharps containers 255 exposed. The sequential numbering 259on the channels can be clearly visible when the surgeon places the usedneedles 104 into the sharps containers 255. The tip of the needle drivercan fit within the channels so the proximal ends of the used needles 104will be completely within the protective channels. It is also possibleto place one or more suture packets 101 on the uncovered surface of thefirst sharps container 255 as described previously. In other embodimentsas shown in FIGS. 139-140, the sharps containers 255 can be arranged ina vertical manner with only the used needle input ends exposed. Thenumber markings 259 can be seen on the exposed elastic layer 251 by thesurgeon.

In some embodiments of the present invention, locking mechanisms 265 canbe used with the sharps containers 255 as shown in FIGS. 153 and 154.The locking mechanisms 265 can allow the needles 104 to be inserted butmay prevent the used needles 104 from being removed. In an embodiment, alocking mechanism 265 can be located within each of the channels of asharps container 255. The walls of the channel can taper to guide thetip of the needle 104 to the locking mechanism 265 and the lockingmechanism 265 can include one or more hinged arms 268 that can beoverlapping on opposite sides of the channel. With reference to FIG.154, when the needle 104 is pressed into the locking mechanism 265, thearms 268 can deflect downward so that the arms 268 are pressed againstopposite sides of the used needle 104. The arms 268 will then clamp downon the needle 104 to prevent it from being removed from the channel thuslooking the used needle 104 into the sharps container 255.

In other embodiments with reference to FIGS. 155 and 156, the lockingmechanism 265 can include multiple cams 275. The used needles 104 can bepressed through multiple cams 275 which are mounted on opposite sides ofthe channel 277. The cams 275 can rotate downward to allow the needles104 to enter the sharps container 255. If an upward force is applied tothe needles 104, the cams 275 will rotate upward and clamp the oppositesides of the needle 104 at each cam 275 to prevent the needles 104 frombeing removed. In other embodiments, various other locking mechanismscan be used to prevent the used needles 104 from being removed from thesharps container.

In an embodiment, the sharps containers 255 can have indicators thatindicate that the needle is properly placed in the channel 277 of thesharps container 255. In the illustrated example, foam indicator blocks279 can be mounted just below each of the cams 275. The friction forceof the foam 279 against the sides of the channel 277 can hold the blocks279 in place. After the needle 104 tip passes through the cams 275, itcontact the upper surface of the foam indicator block 279 and thedownward force of the needle 104 can move the foam block 279 to a lowerportion of the channel 277. Eventually, the foam block 279 may contactthe bottom of the channel 277 and the used needle 104 can be furtherinserted into the foam block 279 without any additional movement of theblock 279. In an embodiment the foam block 279 can be concealed in theupper position and visible in the lower position so that users caneasily see if the channel 277 of the sharps container 255 is filled witha used needle 104. FIG. 155 illustrates the sharps container 255 withthe foam blocks 279 in the upper positions covered with numericalmarkings 259.

In other embodiments, other types of locking mechanisms and indicatorscan be used with the sharps container. In an embodiment illustrated inFIGS. 151-152, the used needles 104 can be electrically conductive andmagnetic. FIG. 151 illustrates sharps container 255 with the electricalcircuitry and locking mechanism 265 visible. FIG. 152 illustrates thesharps container 255 with the electrical circuitry and locking mechanism265 covered with numerical markings 259. The channels 277 can have anupper electric circuit for a light indicator system. The upper lightindicator circuit is normally open with the light 267 off. The needle104 is placed into the locking mechanism 265, which is electricallyconnected to light 267 and a positive or negative lead of the battery269. When the needle 104 is pressed through the locking mechanism 265 toa lower conductor 271 the electrical contact of the used needle 104closes the circuit illuminating the channel light 267. Because theneedle 104 is locked in place, the light 267 will remain illuminated.

In the illustrated embodiment, the lower circuit turns on theelectromagnet 273 when the tip of the needle 104 is adjacent to theelectromagnet. In this embodiment, the lower circuit is completed whenthe needle 104 which is in contact with the middle conductor 270 alsotouches the lower conductor 271. This electrical connection between themiddle conductor 270 and lower conductor 271 completes the circuit andcauses the electromagnet to energize pulling the needle against theelectromagnet 273. It would be easy to slide the needle 104 against acharge electromagnet 273 so it should be energized once the needle 104is in the proper position. In this embodiment, the electromagnet 273provides a locking mechanism that prevents the needle 104 from beingremoved from the sharps container 255. The electromagnetic 273 lockingmechanism can be used alone or in combination with other lockingmechanisms.

In other embodiments, the sharps container 255 can have battery 269 andcontrol electronics that senses presence of needle 104 and keeps ongoingcount and has indicator lights 267 or display that lets operator knowthe relative or absolute absence of needle same device can containtransmitter to communicate wirelessly with other devices and electronicsincluding via Bluetooth or low frequency low energy transmitterincluding tablets, computers, mobile phones etc. Sensors may senseimpedance changes, weight, electrical resistance, volumetric, etc. Thesensor information can be used to indicate the number of used needles104 in the sharps container for the purpose of providing an accurateused needle 104 count. The electromagnet 273 can work through a plasticlayer. Therefore in some embodiments, the used needles 104 are not indirect contact with the electromagnets 273. When the used needles 104need to be removed from the sharps container 255, the electromagnets 273can be turned off. In an embodiment, electromagnet 273 can be used tosecure the sharps container 255 to a magnetic forearm platform.

As discussed above, the needle receptacle and suture packet assembly canbe placed on the end of a surgical tool. The prior example illustratedsuture packets on the exposed sides and a used needle receptacle alongthe edge of the assembly. In other embodiments as illustrated in FIG.142, it is also possible to have the used needle receptacles on theexposed sides and the suture packets placed on the edge of the assemblybetween the used needle receptacles. In the illustrated example, theproximal ends of the new needles 103 in the suture packets 101 can beexposed and extend away from the edges of the used needle receptacles257. In an embodiment with reference to FIG. 141, the portion of thesuture packet 101 adjacent to the proximal ends of the new needles 103can be bent or removed to expose the proximal ends along the dashedline. With reference to FIGS. 144 and 145, the suture packet 101 and theproximal end of a surgical tool 201 can then be positioned against thebacks of the used needle receptacles 257 to form a used needlereceptacle and suture pack assembly 258. The used needle receptacles 257can be secured to the proximal end of the tool 201 with an adhesive orany other suitable coupling mechanism.

The surgeon can grasp a proximal end of a new needle 103 from the usedneedle receptacle and suture pack assembly 258 and install the suture.The surgeon can then insert the used needle 104 in the next sequentialspace in the used needle receptacle 257. The surgeon can then graspanother new needle 103 and repeat the process. This process is moreefficient because the surgeon does not need to reply upon a scrub techto handle needles and needle drivers. This process is also safer becausethere is limited, or no coordinated handling of needles between thesurgeon and the scrub tech reducing the risk of mishandling.

Embodiments of the present invention are directed towards sharpscontainers that can provide a lightweight structure that securely storebetween about 2-20 used needles in the immediate proximity of thesurgeon. The sharps container can be less than approximately 4 inches inheight or length, 4 inches in width and 3 inches in thickness and can beheld on a surgical tool, a platform supported by the surgeon or anyother movable structure controlled by the surgeon. The inventive sharpscontainer can have an internal volume for storing the used sharps and inan embodiment, the container can have a movable door that can be open toinsert the used sharps and closed to prevent the used sharps fromescaping. The shape of the sharps container can be cylindrical, boxshaped or any other suitable shape that has an internal volume that islarge enough to store about 2-20 used needles 104. Because the usedsharps container can be on the end of a surgical tool, the weight of theused sharps container is preferably less than 0.100 lbs. or 45 grams.

In many embodiments, the surgeon takes responsibility for securing theneedle or group of needles prior to passing to the assistant. The sutureneedles can be curved solid needles that pass through tissue. Thus,these needles pass through very small holes in the tissue and theneedles cannot have adaptions on the back end of the needle to slideover the needle to safely secure the sharp used needle tip in at leastsome embodiments.

In an embodiment, the present invention provides a means for safelysecuring the used surgical needle in the surgical field with theshortest route for the contaminated needle from tissue to a used sharpscontainer. The process is substantially shorter because the needle onlytravels a short distance that is normally less than one foot, forexample within the near surgical field.

The design and use of the inventive sharps container as described andillustrated has physical properties that do not interfere with thesurgeon's workflow in closing patient wounds. Work in relation toembodiments suggests that securing used needles to a sharps containerpositioned on the instrument or on the surgeon's forearm or handactually expedites the procedure, in addition to making the proceduresafer. There can be no shorter physical path for the needle to a sharpscontainer that is attached to hand/forearm or back of surgical tools onthe surgeon's anatomy. Thus, the inventive system also minimizes thedistance that the used needles must travel and eliminates unnecessarymovement of the used needles, which increases the efficiency and reducesthe required time. The inventive process has the benefits of onlyrequiring the surgeon to perform the entire task, which minimizes thehandling of a used sharp needle which increases the safety of theinventive system.

FIG. 146 is a block diagram of an apparatus 308 comprising an integratedsuture packet and needle receptacle, in accordance with embodiments. Inan embodiment of the present invention, a plurality of new needles 103can be packaged with a sharps container or needle receptacle 257 as asingle integrated unit 308 that can share the same housing 309. Theneedle receptacle may comprise any sharps container or needle receptacleas described herein (e.g., used needle receptacle 191, sharps container257, needle trap 331, etc.), configured to secure a plurality ofdispensed suture needles 104. The integrated suture packet and sharpscontainer can include a predetermined number of new needles and a sharpscontainer that includes sufficient room for at least the predeterminednumber of used needles. For example, in an embodiment the integratedsuture packet and sharps container can contain five new needles in thesuture packet within or mounted on a first portion of the housing withan optimized sharps container for the used needle that can acceptbetween about five to seven used needles. In other embodiments, theintegrated unit can have any other number of needles, for example, 10 or20 or more. However, the integrated sharps container is preferably ableto hold an equal number or more used needles than new needles.

In some embodiments, the integrated suture packet and sharps container308 share a housing 309, with the new armed needles 103 accessible froma first side 303 of the housing, and the sharps container 257 disposedon a second side 304 of the housing. For example, in a first embodimentthe surgeon may use a needle driver to grasp an armed needle from afirst side of the housing. The surgeon can use the suture and place theused needle in the sharps container through a door in a second side,such as the top surface, of the housing. The user can open the door toinsert the used needle and then close the door to prevent the usedneedle from escaping.

In other embodiments, a protective door can be closed to shield thearmed needles. This can be useful if the integrated suture packet andsharps containers are placed in storage to protect the needles. Indifferent embodiments, the protective doors can be opened in variousdifferent ways. In an illustrated embodiment, the door may slide side toside or up/down so that the surgeon can easily open the door to accessnew armed needles. In other embodiments, multiple doors can open toallow access to the armed needles. In some embodiments, the protectivedoor can be manually operated. In other embodiments, an actuator can beused to control the position of the protective door. The housing canalso have an outer surface which can be used for labels or markings toprovide needle and/or housing information.

Such an integrated configuration of a suture pack and a needlereceptacle can provide improved safety and efficiency benefits describedherein. Sharps containers can have many different varieties including:foam with demarcations that allow for multiple needles, foam encased inan outer shell such that needles cannot pass out the sides of the shell,foam encased in the outer shell having an aperture for introducing theused needles, the aperture is more narrow that the width of the housingsuch that with the bend of the needle, the housing will capture theneedle tip. The foam represents a reservoir type vehicle for capturingneedles in which the surgeon has flexibility on the orientation andlocation to place the used needles.

Another sharps container embodiment includes specific holes into whichthe needles are place by the surgeon. The used needles can go in but themechanism captures the needle and does not allow removal of the usedneedles 104. Such mechanisms can include a cone with tapered tip andmalleable leaves that bend to allow needle passage but preventremoval-similar in shape to lobster trap. Another mechanism is a cam orseveral cams with ratchet. As a used needle is introduced the camsrotate and compress the tip of the needle. Rotation of the cams can alsoexpose side of the cam with a color change indicating the presence ofthe needle. There many potential mechanisms for capturing individualneedles at fixed location.

FIGS. 147A-149 illustrates exemplary embodiments of a sharps containerin the form of a cartridge. The cartridge can be attached to theinstruments that are typically used in the non-dominant hand such as thesurgical pickups, Adsons, Bonneys, etc. The cartridge can be designed tobe secure to the pickups and can include a mounting mechanism that canallow the cartridge to be easily attached and detached from the tool orstructure. In addition to the sharps container, the cartridge can alsoinclude one or more needle packages and broad labeling on an outersurface of the housing that can be easily visible to the surgeon. FIG.150 illustrates an embodiment of a sharps container 255 coupled to asurgical instrument 201.

In an embodiment, the cartridge can include an attachment mechanism(s).The attachment mechanism can be used to couple the cartridge to anotherobject such as a tool or a platform. In an embodiment the attachmentmechanism can be a slot or slots or holes in the cartridge into whichthe non-surgical end of the pickup attaches, or can incorporate andadaption of the surgical pickup. In other embodiments, the attachmentmechanisms can include permanent magnets which can be used to secure thecartridge to the tool. With reference to FIG. 157 in the illustratedexample, the cartridge 281 has two holes 283 which correspond to twoelongated rods 285 that extend from the proximal end of a forceps tool201. Permanent magnets 287 can also be mounted at the proximal end ofthe forceps tool 201 so that the magnets 287 in the cartridge 281 willbe attracted to magnets 287 in the forceps tool 201 and the magneticattraction will hold the cartridge 281 in place. The cartridge 281 canbe separated with a force greater than the magnetic attraction force isapplied.

In other embodiments, a pure mechanical locking mechanism can be used tosecure the cartridge to another object. In an illustrated example FIGS.158-159, the bottom of the cartridge 281 has two tabs 289 which canengage corresponding recesses 291 in a coupling. When pressed together,the tabs 289 can deflect inward so that the outer surfaces of tabs 289slide against the inner surfaces of the coupling. The tabs 289 can thenengage the slots 291 in the inner surfaces of the coupling to rigidlysecure the cartridge 281 to the top of the forceps tool 201. The usercan squeeze the tabs 289 inward through the slots 291 to disconnect thecartridge 281 from the forceps tool 201.

In different embodiments, the fresh needle side of the cartridge canhave a protective cover or door that moves or slides to expose the armedneedle. The protective cover or door mechanism can be actuated in anydirection, up down or sideways.

The cartridge can have an oval cross section with the fresh needlesrecessed from the face. Once the cover or door is open, the freshneedles are accessible to the surgeon.

The sharps container can be closed cell foam on the contralateral sidethat also is marked and has an aperture on the face. The foam may extendto the full border of the face to facilitate the capture and retentionof the used needles 104. The walls of the cartridge are not penetrableby the needle to protect the needle from coming out of the side of thehousing.

The sharps container can have a magnetic base that can help to preventused sharps from accidental removal and the sharps container can also bea clear transparent structure that can allow the used needles 104 to bemore easily counted. The sharps container can have a dome coverage thatallows used needles 104 to pass through by rotating the needle through asmall aperture so needle can enter the sharps container at any angle.The sharps container may include a magnetic base with covers that lockin place as needle placed in the container. Locking or closing thesharps container lid may expose the next new armed needle(s) or actuateand open the door covering the new needles.

With reference to FIGS. 160-166 in yet another embodiment of the sharpscontainer, a hole 293 is a housing 295 can be covered with a thin layerof elastic foam 263. A larger width volume of the sharps container canbe located under the hole 293. Thus, when a needle 104 is placed intothe foam 263 over the hole 293, the needle 104 will pass through thefoam 263 and the middle portion of the needle 104 may be positionedwithin the hole 293 and the sharp tip can be within the wider volumebelow the hole 293. In an embodiment, this embodiment of the sharpscontainer can include a layer of elastic foam 263 that can be betweenabout 1-10 mm thick covering an underlying hole 293 that can be betweenabout 2-50 mm in diameter or wide. The hole 293 depth can also bebetween about 2-50 mm. The foam material 263 can be bonded to the top ofthe housing 295 and can cover the hole 293 like a drum. Thisconfiguration can have several benefits. The needle 104 tip can moreeasily pass through the foam 263 layer with less force than a thickerfoam layer. However, the thinner foam 263 layer still provides enoughsliding resistance to prevent the used needles 104 from becomingdislodged by gravity. The proximal aspect of the needle 104 will stillremain above the foam layer 263.

Forces on the proximal aspect of the needle 104 do not need to be verylarge to cause the needle 104 to be further advanced through the foam263 layer or rotate the needle 104 within the foam 263. The foam 263 canalso allow for low force angulatory displacement of the needle 104relative to the plane of the foam 263. Thus, if a side force is appliedto the exposed proximal portion the needle 104 will simply bend relativeto the plane of the foam 263. Under the foam 263, there is a sufficientvolume for the distal tip of the needle 104 to move around within thesharps container housing 295. Because the foam 263 can allow formovement of the needle 104 even after it has been inserted, there is areduced risk of injury to human skin by the proximal aspect of theneedle 104. As discussed, a downward force on the needle 104 will causeit to be pushed further through the foam 263 into the sharps containerand a horizontal force will cause the needle 104 to rotate about thefoam 263 entrance point.

In different embodiments, the hole 293 size and the foam 263 thicknesscan both be variable. The size and physical properties of the foam 263and hole 293 can be selected to provide optimized functionality basedupon the types of needles 104 being used. Smaller needles 104 arelighter weight can use thinner lower density foam 263 over a smallerhole 293 while longer needles 104 may need thicker higher density foam263 over a larger hole 293. The shape of the underlying volume of thecontainer will need to be optimized to allow for maximal needle 104 tipexcursion.

In an embodiment, the position of the holes 293 can be indicated bycorresponding circular markings 297 on the exposed side of the foam 263so that the user can easily locate the holes 293 under the foam 263layer. The holes 293 can be numerically marked 259 so to help withneedle 104 counts. The hole 293 can be part of a tubular structure thatextends into the housing 295 as shown in FIGS. 160 and 162.Alternatively, the hole 293 can be planar with the wall of the sharpscontainer structure housing 295 as shown in FIGS. 161 and 163.

With reference to FIG. 166, in an embodiment, the sharps container caninclude many holes 293 that are each covered with a foam 263 layer. Eachof the holes can be marked with a circular marking 297 to visuallyindicate the locations of the holes 293. A sequence of numericalmarkings 259 can also be placed within each of the circular markings 297to aid with the needle count. The used needles can be sequentiallyplaced in different circular markings 259 through the foam 263 in theorder of the numerical markings 297 which can simplify the counting ofthe used needles.

In other embodiments with reference to FIGS. 164 and 165, it is possibleto modify the device above the plane of the foam 263 to further limitaccess to the proximal aspect of the needle 104. For example, in anembodiment, sharps container can include protective structures 299 onopposite sides of the needle insertion hole. For example, the protectivestructure 299 can have two trapezoidal openings orthogonal to oneanother. The user can insert the used needle 104 into the trapezoidalopenings, through the foam layer 263 and into the underlying hole 293.It is also possible to have a large number of used needle holes 293 inthe sharps housing 295 that are each similar to the described usedneedle 104 hole structures. Again, the position of the hole 293 can bevisually indicated by the circular marking 297 and the numeric sequenceof the hole 293 can be indicated by the numeric marking 259.

In an embodiment, a modular medical device comprising a forearm-mountedpuncture barrier functions as a platform upon which one or more usedneedle repositories and/or one or more suture packs or suture packcarriers can be mounted. The used needle repositories and the suturepacks/carriers can be coupled to the forearm mounted puncture barrier byany of the coupling mechanisms described above or by any other suitablemethod. The used needle repositories can include various needle trapdevices and the suture pack carriers can include a clip for holding asuture pack to the forearm mounted puncture barrier. The needle trap canbe removable from the forearm mounted puncture barrier and is intendedfor replacement when the device has secured the intended number ofcontaminated needles.

An embodiment of a used needle trap is illustrated in FIG. 168, which isa top view of the needle trap 331 with suture pack holder 351, which canhold suture pack 101, and suture pack 353. In the illustratedembodiment, the needle trap 331 can be a planar device that is comprisedof several zones: 1) an entry zone 333, 2) an entryway or transitionzone 335 and 3) the secure zone 337. The needle trap 331 can include anupper structure 339 and a lower structure 341 that are securely coupledtogether around an outer portion of the needle trap 331. The needle trap331 can have a needle driver slot 343 extending through both the upperstructure 339 and a lower structure 341, the needle driver slotconfigured to provide clearance for the needle driver along the entirelength of the needle translation from entry zone 333 to secure zone 337.The needle trap can further comprise a needle slot 349 that constrainsthe secured needles into a single needle depth array, to minimizeoverall depth profile and facilitate needle counting. The configurationof the needle trap 331 can be described with reference to an X axis thatextends from left to right and Y axis extends up and down when viewingthe front or top of the needle trap 331 from the perspective of thesurgeon, and a Z axis which defines a depth position.

In an embodiment, the entry zone 333 of the used needle container 331can be a partially circular flat zone or area in the X-Y plane that isan exposed part of the lower structure 341. The surgeon can hold theused needles 104 with a needle driver and place the used needles 104 onan upper surface of the entry zone 333. The contact and/or force of theneedle 104 against the entry zone 333 can cause the curvature of theused needles 104 to be moved into a planar orientation flat against thelanding zone surface X-Y plane with the convex mid-portion of the curvedneedle 104 facing or pointing towards the transitional zone 335.

The entry zone 333 can be wider (y-axis) relative to needle slot 349 andthe perimeter around the entry zone 333 can have a contrasting color toaid visual recognition. The upper surface of the entry zone 333 surfacecan include a low friction material. Graphic guides on the entry zone333 surface can help to reinforce needle 104 rotational orientation. Theneedle driver slot 343 can extend into the entry zone 333 and the widthof the needle driver slot 343 can be greater or oversized in the entryzone to facilitate fast location of the entrance to the needle trap withthe needle driver. The needle driver slot can taper as it extendsthrough the transition zone 335 towards the secure zone 337, to providea self-centering close fit with the tip of the needle driver in thetransition zone 335 and secure zone 337.

The transition zone 335 is disposed between the entry zone 333 and thesecure zone 337. In the transition zone, the compressive side load onthe needles ends may be increased and the depth (z-axis) of the needleslot can narrowed as the secured needles are translated through thetransition zone, constraining the needles to a single needle deep arrayextending longitudinally along the secure zone 337.

The secure zone 337 comprises the region adjacent to the transition zone335, in which full compressive side loading is applied to the needleends to prevent unintentional removal or dislodging of the needles.

The boundary 345 may be concave, wedge or “V” shaped, with the apex ofthe “V” shape pointing towards the secure zone 337 to promote properorientation of the needles 104.

In an embodiment, the transition zone 335 can include a concave, wedgeor “V” shaped boundary on a side of the entry zone 333 in the upperstructure 339 with the apex of the “V” shaped boundary pointing towardsthe secure zone 337 to promote proper orientation of the needles 104.The secured needle 104 in the needle trap 331 can be configured to havethe convex side of the needle 104 facing the secure zone 337 and theconcave side, sharp point and tail of the needle 104 facing towards theentry zone 333. Thus, the needle trap 331 can be configured to have thesharp leading and trailing ends of the needle 104 pointing away from thedirection of motion, thereby reducing the risk of needle-stick injury.The transition zone 335 can have a flared cowling over a portion of thelanding zone and tapered surfaces in both the Y-axis and the Z-axis, toreduce the width and height from the entry zone 337 to a single needleheight and width in the used needle slot 349 as the needle 104 is movedalong the longitudinal X-axis path from the transition zone 335 to thesecure zone 337. The needle driver slot 343 can intersect a portion ofthe needle slot 349, such as a middle portion of the needle slot, andcan be in the midline of the used needle trap 331 in the X-axis suchthat the distal tip of the needle driver can translate the needle 104along the X-axis of the used needle trap 331. Alternatively, the needledriver slot 343 can intersect the needle slot 349 off the midline orasymmetrically, such that the needle driver slot extends along an axissubstantially parallel to, but not overlapping, the X-axis of the usedneedle trap 331. The needles 104 can slide within the needle slot 349deeper into the secure needle zone 337 without excessive resistance orsensitivity as to how the needles 104 are grasped by the needle holder.In an embodiment, the secure zone 337 can prevent used needles 104 frombeing removed from the used needle trap 331.

In a preferred embodiment, the needle 104 is moved into contact with theentry zone 333 of the lower structure 341 by the surgeon manipulatingthe tip of the needle driver in the needle driver slot 343. The needles104 can be pushed against the entry zone 333 and become aligned with theX-Y plane of the used needle trap 331. The needles 104 can then be movedin translation along the longitudinal X-axis of the used needle trap 331from the entry zone 333 into the transition zone 107 where the needles104 slide into the used needle slot 349 with the convex side facing thesecure zone 337 and the sharp tip and tail of the needle 104 facing theentry zone 333. The needle driver can move the used needles 104 into theused needle slot 349 in the secure zone 337 until the needle driver runsinto the end of the needle slot 349 or the last inserted used needle104, or the needle 104 contacts the end stop 363 of the needle slot 349.

In an embodiment, the distal tip of the needle driver holding a needle104 can have an elongated cross section and the width of the needledriver slot 343 can narrow in the secure zone 337 so that the distal tipof the needle driver must be oriented with the longer cross sectiondimension aligned with the needle driver slot 343. This needle driverorientation can also cause the needle 104 properly aligned across thewidth of the secure zone 337 within the needle trap 331. Thus, thenarrowing of the needle driver slot 343 can force the needle driver toproperly orient the needles 104 in the secure zone 337 as the needledriver slides against the sides of the needle driver slot 343 in thesecure zone 337. FIG. 168 illustrates a top view of an embodiment of aneedle trap 331. In different embodiments, the needle trap 331 can havedifferent dimension depending upon the size of the needles 104 beingstored. Thus, a small needle trap 331 used to store smaller needles 104can have smaller dimensions than a large needle trap 331 used to storelarger needles. With reference to TABLE 1 below, the ranges ofdimensions of embodiments of a small and a large needle traps 331 ofdifferent sized embodiments are listed. The length can extend along theX-axis, the width can extend along the Y-axis and the thickness canextend along the Z-axis. The entry zone 333 can have a circular portionand the “entry zone radius” can be the radius range of the circularportion. The needle slot thickness can be the range of distances betweenthe lower surface of the upper structure 339 (not including theprotrusions 361) in the secure zone 337 and the upper surface of thecompressible members 347. In other embodiments, the needle traps 331 canhave any other dimensions which will allow the storage of needles 104.The dimensional ranges in table 1 are in inches.

TABLE 1 Entry zone Needle slot Size Length Width Thickness radiusthickness Small 2.5 to 4.5 0.8 to 2.0 0.1 to 0.5 0.5 to 1.0 0.01 to 0.05Large 3.0 to 5.5 1.0 to 3.0 0.2 to 0.8 0.7 to 1.5 0.02 to 0.10

In the secure zone 337 the Z-axis depth of the needle slot 349 narrowsso as to compress against and orient the used needles 104 in parallelalignment with the needles 104 positioned across the width of the needleslot 349 and center portions of the used needles 104 spanning across theneedle driver slot 343. Once the needle 104 has been fully inserted intoand can proceed no further in the X direction the surgeon can releasethe used needle 104 in the secure zone 337 and this process can berepeated for the next used needle. The tip and trailing ends of the usedneedles 104 can be secured within the used needle slot 349 in the securezone 337 between the lower structure 341 and the upper structure 339.Once the surgery is completed or when the used needle trap 331 is fullor during a medical procedure, the used needles 104 stored in the needletrap 331 can be easily counted. In FIG. 168, seven used needles 104 areshown in the secure zone 337.

FIG. 169 illustrates a top perspective exploded view of the needle trap331 with a suture pack 101, FIG. 170 illustrates a side perspectiveexploded view and FIG. 171 illustrates a bottom perspective explodedview. The needle trap 331 may comprise an upper structure 339, lowerstructure 341, compressive members 347, foam connectors 357, entry zonesuture pack holder 351, and adhesive pad 355. A plurality of usedneedles 104 may be secured in the needle trap, and one or more suturepacks, such as suture pack 101 holding one or more suture needles 103,may be coupled to the suture pack holder 351 and/or the adhesive pad355.

The upper structure or front cover shell 339 comprises the top halfportion of the needle slot 343, and can be joined to the lower structure341 by adhesive bonding or ultrasonic welding. The upper structure maycomprise an injection molded clear polycarbonate, or other opticallytransparent material. The inner surface of the upper structure may haveprotrusions or nubs 361, intended to provide separation between securedneedles, to increase resistance against the removal of secured needles,and to provide tactile feedback during translation of needles from entryor transitional zone into the secure zone. The inner surface of theupper structure may have a protruding needle stop 363, intended toprevent needles from being translated beyond the needle driver slotwhich would prevent accurate visual counting. The upper structure thatcovers the transition zone 335 is flared at the boundary 345 toward theentry zone 333 to present a deeper (z-axis) spatial target for fastlocation of the entrance to the trap with the needle driver.

The lower structure or rear shell 341 comprises the bottom half portionof the needle slot 343, and can be joined to the upper structure 339 byadhesive bonding or ultrasonic welding. The inner surface of the lowerstructure may have wells or recesses 359 within which the compressivemembers 347 may be adhesively attached. The recesses may decrease indepth within the transition zone from the entry zone to the secure zoneto increase compressive side load on needle ends. The deeper recesses atthe boundary of the entry and transition zones can prevent the end ofthe compressive members from being displaced by the needles duringtranslation. The outer surface of the lower structure can incorporaterecesses within which the foam connectors 357, adhesive pad 355, andsecure zone suture pack holder 351 may be adhesively attached. The wallsof the recesses can provide a standoff to provide separation between theneedle trap and barrier mounting surface for the needle driver tip. Thelower structure may comprise injection molded colored polycarbonate, ora material similar in composition to the material of the upperstructure.

Compressive members 347 can comprise open cell urethane foam stripsadhesively bonded to the lower structure 341. The compressive memberscan provide side load compression on the ends of the used needles alongthe secure zone.

The foam connectors 357 can provide an attachment interface between theneedle trap 331 and a barrier or platform as described herein. The foamconnectors may be adhesively attached within recesses to the outersurface or underside of the lower structure 341. Loop connectors may beadhesively attached to the exposed foam surface, which can extend abovethe recess walls and provide a means of attachment to corresponding hookconnector adhesively attached on the exterior barrier surface.

The secure zone suture pack holder 351 can provide a means topermanently attach a suture pack 101 next to the needle trap 331,providing a means for proximity reconciliation in real time by both thesurgeon and operating room assistants in the near surgical field. Thesuture pack holder may comprise a closed cell foam pad, adhesivelybonded to the outer surface of the lower structure 341. The exposed topsurface of the holder may be covered with pressure sensitive adhesivefor attachment to the rear surface of a suture pack. Loop connectors canbe adhesively attached to a raised surface 344 on the bottom surface ofthe suture pack holder, and provide a means to attach to a hookconnector on a barrier or platform as described herein.

The suture pack holder can be configured to flex between the needle trapand attached suture pack to enable the combined assembly to assume alower profile when mounted on the forearm by “tenting”. Alternatively orin combination, the suture pack holder can be coupled to the needle trapvia a hinge 346, as shown in FIG. 167. The hinge can reduce the profileof the assembly, by allowing the suture pack holder to “tent” about thehinge rather than extend straight up.

The adhesive pad 355 can be attached to the outer surface or undersideof the lower structure 341, underneath the entry zone. For example, theadhesive pad may be attached to the lower structure with pressuresensitive adhesive. The exposed surface of the adhesive pad can becovered with pressure sensitive adhesive providing a means to attach asuture pack 353 under the entry zone of the needle trap, along thelongitudinal axis of the forearm (x-axis). An additional piece of loopconnector may be attached to the underside of the suture pack 353, toenable additional stabilization of the suture pack by attaching to ahook connector on a barrier or platform as described herein.

The used needles 104 can be held in the needle slot 349 between an upperstructure 339 and a lower structure 341. Compressive members 347 can beplaced on the lower structure 341 below the needles 104 in the securezone 337. In an embodiment, an elastic and/or compressible member 347material can be foam, rubber, elastic plastic or any other suitablematerial or mechanisms that can be attached to the inner surfaces of thelower structure 341 facing the needle slot 349. In the illustratedexample, compressible member 347 can have a uniform thickness andleading edges of the compressive members 347 can be bend downward at theleading edge (towards the entry zone 333). In the illustratedembodiments, the compressive members 347 can fit within recesses 359 inthe lower structure 341. The leading edges of the recesses 359 can bedeeper than the other portions of the recesses 359 and this curvature ofthe compressible member 347 can provide a gradual narrowing of theneedle slot 349 as the used needles 104 slide over the compressiblemember 347 into the secure zone 337.

With reference to FIG. 171 a series of protrusions 361 can extenddownward from the upper structure 339 on both sides of the needle driverslot 343. As the needles 104 are inserted into the needle trap 331, thecompressible member 347 can press the needles 104 against theprotrusions 361. The protrusions 361 can resist the movement of theneedles 104 along the X-axis and prevent the needles 104 fromaccidentally sliding out of the secure zone 337 of the needle trap 331.A needle stop 363 can be positioned close to the end of the needledriver slot 343. The needle stop 363 can prevent the needles 104 frombeing placed away from the needle driver slot 343.

In different embodiments, the secure zone 337 can incorporate othertypes of retention systems. For example, the retention system caninclude a compressible member 347 which can be fabricated from: foam,Velcro loop or any other suitable media. The compressible member 347 canbe compliant and can compress the needles 104 against the bottom side ofthe upper structure 339 between retention features. The compressiblemember 347 can have a dimensional interference with the protrusions 361.In an embodiment, the density of the retention media material can beless than or equal to 4 lb. For example, the retention media materialcan be polyethylene or polyurethane foam which can provide a lowcoefficient of friction against a sliding needle 104.

In the illustrated embodiment, a suture pack 101 can be attached to asuture pack holder 351 that can be can be attached to the secure zone337 portion of the needle trap 331 with an adhesive. In anotherembodiment, another suture pack 353 with sutures 103 can be attached tothe entry zone 333 with an adhesive 355. The suture pack holder 351and/or suture pack 353 can provide a rigid base under the suture pack101 which can prevent the suture pack 101 from being bent while attachedto a forearm barrier or any other structure. Bending of the suture pack101 can result in loosening of needles 103 in their mounts which canpotentially result in a lost needle 103. The suture pack holder 351and/or suture pack 353 can is designed to either extend from or beattach as separate pieces to the needle trap 331. In an embodiment, thesuture pack holder 351 and/or suture pack 353 and the trap 331 can bemanipulated into a compact or flat space saving configuration forshipping and storage and then expanded into the illustratedconfiguration prior to use.

In an embodiment, the needle trap 331 and suture pack holder 351 and/orsuture pack 353 can be attached to another structure such as aprotective barrier worn on a forearm of a surgeon using variousdifferent types of connection mechanisms. For example, the needle trap331, suture pack holder 351, and suture pack 353 can be attached toanother structure such as a protective barrier with a hook and loopconnection mechanism. At least a portion of the protective barrier canbe covered with a hook material which can be adhesively bonded to theprotective barrier and back portions of the needle trap 331, suture packholder 351, and suture pack 353 can be adhesively bonded to a loopmaterial. In another embodiment, the needle trap 331 can be attached toa barrier or any other object with adhesive backed foam 357. In anembodiment the needle trap 331 can include one or more pieces coupled toa back surface of the lower structure 341.

Although the needle trap has been described and illustrated as having aspecific configuration, in other embodiments various otherconfigurations of components can be used to hold the needles in theneedle trap. For example in an embodiment, the compressive members 347illustrated in FIG. 176 can be replaced with elastic strips that aresecured in the secure zone on either side of the needle driver slot. Theelastic strips can include a plurality of elastic protrusions, which canextend up towards the upper structure. When the used needles are movedacross the exposed surfaces of the elastic strips with the needledriver, the protrusions can push the needles up against the upperstructure and the protrusions extending inward from the upper structure.These forces and protrusions can prevent the used needles from movingfreely within the secure zone of the needle slot.

In other embodiments, other mechanisms can be used to keep the usedneedles in the secure zone of the needle trap. For example, the usedneedle container can include magnets mounted on the upper structureand/or the lower structure on opposite sides of the needle driver slot.The needle driver can be used to move the used needles into the needleslot and when the needles are released, the magnets can hold and securethe needles within the secure zone.

With reference to FIG. 177, a front view of an embodiment of a needletrap 331 is illustrated. In the illustrated embodiment, the needle trap331 can include elastic materials 365 such as foam or other elasticmaterials coupled to the upper structure 339 and the lower structure 341on either side of the needle slot 349. When the needles 104 are placedin the needle slot 349 the elastic foam can contact opposite sides ofthe needles and prevent the needles from moving within the secure zoneof the needle trap 331.

Although the elastic material 365 is illustrated as having flat innersurfaces, in other embodiments, the elastic material 365 can havevarious surface features. For example with reference to FIG. 178 a crosssection side view of the needle slot 349 of the needle trap 331 isillustrated. The surfaces of the elastic material 365 that face theneedle slot 349 can include depressions or protuberances on the surfacefacing needle slot 349 in the secure zone 337. In the illustratedexample, the surfaces of the elastic material 365 can have rampedsurfaces which can be configured to allow the needle 104 to more easilybe moved into the secure zone 337 and resist the remove of the needles104 from the secure zone 337. The depressions and/or protuberances cancause the needles 104 to have a predisposition to seat at the properinterval positions in the secure zone 337. The depressions andprotuberances can provide positional cues for the surgeon with thesubtle force reduction to place and secure needles 104 at that thedesignated location.

With reference to FIG. 179 a top view of the secure zone 337 portion ofthe lower structure 341 in an embodiment of the needle trap 331 isillustrated. In the illustrated embodiment, the opposite sides of theneedle slot 349 can be lined with angled bristles 365 on opposite sidesof the needle driver slot 343. The bases of the bristles 365 can beattached to the outer side portions of the needle slot 349 and theremaining portions of the bristles 365 can bend relative to the bases.The arcuate needles 104 are moved through the secure zone 337 betweenthe bristles 365 and the bristles 365 can bend inward away from theneedle slot 349 to allow the needles 104 to be inserted into the securezone 337. However, the bristles 365 can prevent the needle 104 frommoving in the opposite direction because the bristles 365 would engagethe ends of the needle 104 which would move inward towards the needleslot 349 and resist the movement of the needle 104 out of the securezone 337. Thus, the bristles 365 result in less force to translate theneedle 104 from the entry zone 333 into the secure zone 337 than theforce required to remove the needle 104 from the secure zone 337.

A feature of the needle trap 331 is the ability to easily count needlesthat are placed in the secure zone 337. As illustrated in FIGS. 168 and172, the used needles 104 in the secure zone 337 of the needle trap 331are visible through the needle driver slot 117 and can be easilycounted. In other embodiments, the upper structure 123 can be made of atransparent or translucent material so that the used needles 104 can beviewed through the upper structure 123. In an embodiment, the usedneedles 104 can be counted by a second individual (other than thesurgeon) who is responsible for keeping track of the used needles 104.The needle trap 331 can allow the secured needles 104 to be visible froma distance so that the second individual can easily count the number ofneedles 104 in the needle trap 331. As discussed, the used needles 104can be positioned in parallel in the secure zone 337 with a spacing ofabout 3 mm to 10 mm between adjacent needles 104 to facilitate accurateneedle counting. In an embodiment, the needle trap 331 can have achamfered or filleted needle driver slot 343 edges can be colored orpainted to maximize reflectivity and provide a visual contrast toneedles 104 visible through the needle driver slot 343. For example, theedges of the needle driver slot 343 can be white.

FIGS. 172B-172D show top, side and end views, respectively, of theneedle trap 331 of FIG. 172A. Needle trap 331 comprises a housing 340 tocontain dispensed needles. The housing 340 comprises upper and lowerstructures as described herein.

Housing 340 defines needle slot 349, which comprises channel slot 349having an elongate cross section sized to receive the plurality ofneedles. The housing 340 comprises an overall length L, an overallthickness T, and a first width W1 comprising an overall width, and asecond width W2. The needle driver slot 343 comprises a width S toreceive needles. The driver needle slot comprises a length dimensionedlarger than a width of the slot to allow placement of a plurality ofneedles in the secure zone. The needle driver slot comprises a guide toguide the needle driver as the needle driver and needle are advancedalong the slot. An upper flange portion F1 and a lower flange portion F2extend from the housing 340. The upper flange portion F1 can be flaredupward to facilitate needle placement in the slot. Alternatively or incombination, the lower flange portion can be flared downward. The upperand lower flange portions may define a landing zone to receive needlesfrom a needle driver.

The transition zone of the needle slot is dimensioned larger than thesecure zone to facilitate placement of the needles in the needle slot.The elongate needle channel slot comprises a first elongate width CW1near an opening of the needle slot 349, and a second elongate width CW2in an interior secure zone of the needle slot. The elongate needlechannel slot comprises a first thickness CT1 near an opening of theneedle channel slot 349, and a second thickness CT2 in an interiorsecure zone of the needle slot. The first thickness CT1 can be at leastabout twice as thick as the second thickness CT2, for example.

The transition zone of the needle slot comprises a guide in order tofacilitate placement of the needles in the needle slot. The firstchannel width CW1 is dimensioned larger than the second channel widthCW2 in order to provide a larger entry zone to receive needles andfacilitate placement of needles in the secure zone. The second channelwidth CW2 is dimensioned to receive the plurality of needles arranged ina row in the secure zone. The needle slot channel comprises a firstthickness CT1 and a second thickness CT2. The first channel thicknessCT1 is dimensioned larger than the second thickness CT2 in order tofacilitate placement of needles in the secure zone comprising secondthickness CT2. The second thickness CT2 can be dimensioned smaller thana thickness of the needles as described herein in order to contain theneedles with at least some mechanical resistance and deformation of oneor more interior structures, such as a surface or protrusions of theinterior surface. The first thickness CT2 is dimensioned larger than thethickness of the needles placed therein in order to easily place theneedles in the transition zone.

In many embodiments, the needle trap is configured to provide at leastsome resistance to the needle sliding along the needle slot in thesecure zone, in order to stabilize and render innocuous the needle inthe secure zone, such that the needle is secured. One or more of theupper or lower structures of the needle slot can be configured todeflect when the needle is advance into and placed in the secure zone,for example. Alternatively or in combination, the interior of the needleslot channel may comprise structures configured to one or more ofdeflect, deform, stretch or bend within the secure zone in order tostabilize the needles within the secure zone.

Although reference is made to dimensions of the needle trap having asubstantially flat configuration, the needle trap can be configured inmany ways. For example, the needle trap 331 may comprise a conformalmaterial that allows the needle trap to be bent or curved, for example.

In other embodiments, additional devices can be used with the needletrap 331 to facilitate remote counting and tracking of needles. Withreference to FIGS. 180 and 181, in other embodiments, the needle trapcan include an electronic needle counter that can be powered by abattery 373 such as a lithium ion battery or any other suitableelectrical power source. Conductive elements 371 can be mounted in theneedle slot on the compressive members 347 on opposite sides of theneedle driver slot. The conductive elements 371 can be pressed intophysical contact with each needle 104 that is placed in the secure zone337 by the compressive members 347. The electrical counter mechanism caninclude control circuitry 375 and a visual display 377 coupled to thecontrol circuitry 375.

The electrical counter mechanism can comprise an electrical circuit withelectrical current flowing through the needles 104 in the secure zoneand the control circuitry 375. The electrical resistance changes basedupon the number of needles 104 stored in the secure zone in contact withboth of the conductive elements 371. The electrical circuit can have ahigher electrical resistance with fewer needles 104 in the secure zone.The electrical resistance can decrease with more needles 104 in thesecure zone. Each of the used needles 104 can each have an electricalresistance between the conductive elements 371 that is substantially thesame. Thus, each of the used needles 104 can function as a resistor inthe electrical circuit and multiple used needles 104 in the secure zonecan function as a plurality of parallel resistors.

The basic electrical circuit equation is V=I R where V is voltage, I iscurrent and R_(total) is the cumulative needle resistance. Thecumulative electrical resistance can decrease with each additionalstored needle in the secure zone. The equation for parallel resistors is1/R_(total)=1/R₁+1/R₂+1/R₃ . . . . However, the resistances of theneedles can all be substantially equal, i.e. R₁=R₂=R₃ where R₁ is theelectrical resistance of each used needle. The cumulative electricalresistance needles equation becomes 1/R_(total)=N/R₁ or R_(total)=R₁/Nwhere N=number of needles. Thus, the number of needles can be calculatedwith the electrical circuit by V=I R₁/N or N=I R₁/V. Changes in thecumulative resistance and impedance of the parallel needles can alterthe electrical current flowing through the electrical circuit. Thevoltage V and R₁ values can be substantially constant. Thus, changes inthe electrical current (I) are based upon the number of parallel needlesin the secure zone. The control circuitry 375 can include an ammeterthat measures the electric current (I) in the circuit and based upon themeasured current, the control circuitry 375 can calculate the number ofneedles in the secure zone. The control circuitry 375 can output asignal to the visual display 377 that corresponds to the number ofneedles in the secure zone. In an embodiment, the number of needles Ncan be displayed on the visual display 377. With reference to FIG. 180the visual display 377 can display the number “1” which corresponds tothe single needle 104 between the conductive elements 371. Withreference to FIG. 181, the visual display 377 can display the number “5”which corresponds to the five needles 104 between the conductiveelements 371. In other embodiments, the visual display 377 can outputany other display that can indicate the number of needles in the securezone. For example, the display can use individual lights to representeach needle. Each needle in the secure zone can be represented by asingle corresponding illuminated light.

With reference to FIGS. 182-184, in an embodiment, mechanical counterdevices can be used with the needle trap 331 to facilitate needlecounting. In the illustrated embodiment, an arm can be actuated to causea numerical indicator to advance the number displayed. In FIG. 182, asingle needle 104 has been placed in the needle trap 331 and the visualdisplay 377 shows “1”. With reference to FIG. 183, a second needle 104can slide through the needle slot 349 and contact the arm 379 whichrotates about an axis and actuates the visual display 377 to advance thedisplayed number. With reference to FIG. 184, after the second needle104 passes the arm 379, the display 377 has changed to “2” and the arm379 has reset to its normal position detect the next needle 104.

As discussed, the middle portions of each of the needles in the securezone 337 of the needle container 201 are visible through the needledriver slot 343 which can also function as a window. Counting of needles104 can be improved by fabricating a needle container 201 from a clearcasing and clear foam materials an embodiment of which is shown in FIG.185. Depressions 379 in the needle slot 349 boundary surface compressivemembers 347 can provide individual locations for each of the usedneedles. In different embodiments, the compressive members 347 can befoam or any other suitable materials. The used needles 104 can sit inthe depressions 379 which can be used as a visual indicator(s) of thenumber of needles 104 stored in the secure zone 337. A dye may beapplied such that with compression of the compressive members 347 when aneedle 104 is stored can cause the color of the compressive members 347in the compressed area in contact with or adjacent to the needles 104 tochange. In the illustrated example, the needles 104 in the depressions379 can result in a red color marking. A portion of foam or material maybe normally hidden in the compressive members 347 but as the needle 104presses against the dyed material in the depressions 379, the dye(s) canbe released, combined, actuated or any other process that can cause thesurface of the depressions 379 where needles 104 are stored to becolored and become visible.

In another embodiment, a visible red dot can appear wherever a needle ispresent in the secure zone and each dot can represent a different needlein the secure zone. In other embodiments, different color dyes can beused with some or all of the needle depressions. It can be easier tocount different colored dye markings or alternatively, if the dyes arearranged in a repeating sequence. For example a first needle positiondepression can be red, a second needle depression can be blue, a thirdneedle depression can be green, a fourth needle depression can be purpleand a fifth needle depression can be yellow. This color sequence canrepeat for all subsequent depressions in groups of five or any othernumeric interval of depressions. Thus, a sixth needle and eleventhneedle depressions can be red, a seventh and twelfth needle depressionscan be blue, etc.

In an embodiment with reference to FIG. 186, an optical countermechanism can be used with the needle trap to indicate the number ofstore needles 104. An optical scanner(s) 381 can be used to detect thenumber of needles 104 that are stored in the secure zone 337 of theneedle trap 331. The scanner 381 may also be designed to operated inother areas of the radio frequency spectrum such as infrared, UV, radaretc. for the counting function. In another embodiment, a reflectivescanner can be used to quantify amount of metal from strength ofreflected or transmitted optical signal. In an embodiment an infraredimage can detect needles in the needle trap 331 with better accuracythan visual counting from a standard optical image of the needle trap331. The plastics and foam components of the needle trap 331 cantransmit infrared energy whereas the metal needles 104 can reflect theinfrared energy. The optical scanner 381 can transmit scanned needleinformation to a processor 383 that can convert the scanned signal intoa number representing the number of needles 104 in the secure zone 337of the needle trap 331. The processor 383 can be coupled to a visualdisplay 377 that can be controlled to display the number of detectedneedles in the secure zone 337 of the needle trap 331.

With reference to FIG. 187, a camera(s) 385 can be used to detect thenumber of needles 104 that move into the secure zone 337 of the needletrap 331. The cameras can be coupled to a processor 383 that receivesneedle count signals as each needle 104 passes over the camera(s) 385.The processor can count and store the needle count signals and output aneedle count signal to the visual display 377 which can display thenumber of detected needles 104 in the secure zone 337 of the needle trap331. In different embodiments, different types of cameras 385 can beused. For example, the needles 104 can be more visible to an infraredsensor than a visual wavelength optical camera. Thus, an infrared camera385 may more accurately detect the movement of needles 104 into thesecure zone 337.

With reference to FIG. 188, in an embodiment the system can detect thenumber of needles in the secure zone 337 of the needle trap 331 basedupon pressure measurements detected by transducers 387. In theillustrated embodiment, the needle trap 331 transducers can detectcompressions in the compressive member 347 caused by the needles 104.The transducers 387 can be positioned along the length of the securezone 337 and the protrusions 361 can create individual needle storageareas. By measuring the increased pressure in each of the needle storageareas, the number of needles 104 in the secure zone 337 can bedetermined. The transducers 387 can be coupled to a processor 383 whichcan determine the number of used needles 104 in the secure zone 337based upon the transducer 387 signals and the processor 383 can transmita needle count number signal to the visual display 377 which can displaythe needle count number. In different embodiments, different types oftransducers 387 can be used to detect the needle pressure. For example,the transducers 387 can be can be piezoelectric devices that can also beused in which pressure applied to compressive member 347 and records thepresence of each needle 104. Alternatively, the transducers 387 caninclude a series of strain gages that may be utilized to sense thepresence of needles 104 in the secure zone 337 or any other suitablepressure detecting mechanisms.

With reference to FIG. 189, in other embodiments, the needle trap 331can be used with other components to perform needle counting. In theillustrated example, the needle trap 331 can be mounted on a barrier 403that can be placed on a forearm of a surgeon. A needle sensor 389 candetect needle count signals and the needle count signals can betransmitted by a transmitter 391 to a receiver(s) 393 which can becoupled to a processor(s) 383 which can output needle count informationto an output device 395 which can indicate the number of needles in theneedle trap 331. In the illustrated embodiment, the needle sensor 389can be a small camera with an integrated radio frequency (RF)transmitter 391 which transmits image and/or video RF signals toreceivers 393. A processors 383 coupled to the receivers 393 can outputimage and/or video signals to visual displays 337 which can display theneedle driver slot 343 to allow the needles 104 to be visually countedremotely. The needle sensor 389 and transmitter 391 can be within thenear surgical field. In contrast, the receivers 393, processors 383 andvisual displays 337 can be well outside the near surgical field.

The camera can face the needle trap 331 and also possibly the suturepack(s) 101. The images of the needle trap 331 can be transmitted to thevisual display(s) 337 which can be visible to another person. Forexample, the remote visual display(s) 337 can be a video display mountedon an operating room wall. As discussed, a portion of each of theneedles 104 is visible from the upper surface of the needle trap 331through at least the needle driver slot 343. Thus, a displayed image ofthe needle trap 331 on the surgeons forearm can show the number of usedneedles 104 in the needle trap 331 and new suture needles 103 in thesuture pack 101. A surgical assistant can view the display 337 and seethe suture pack(s) 101 and the needle trap 331 with the secured needles104 to track in real time. The surgical assistant can then provideadditional suture packs 101 if additional needles 103 are required andprovide new empty needle traps 331 as the barrier mounted needle traps331 become full of used needles 104 and needs to be replaced. Also, if aneedle 104 is lost the error can immediately be detected by someonemonitoring the surgical procedures or by the processor which can detectthe sequential removal of new needles 103 from the suture pack and thedeliver of the used needles 104 to the needle trap 331. Although anexemplary set of system components has been described, in otherembodiments, the needle count components can include but are not limitedto: dedicated receivers, electronic watches, smartphones, tables,computers, headsets, earpieces, displays, or any other suitable devicefor the purpose of tracking the needles.

As discussed, mid-bodies of needles 104 are visible through the needledriver slot 349 in the needle trap 331. In an embodiment, the processor393 can run a software program that can interpret the visual displaysignals from the needle sensor 389 (camera) and determine the number ofneedles 104 in the needle trap 331 as well as the needles 103 in thesuture pack 101. The processor 393 can then output this needle countnumber on the visual display 377 which can help with the needle countingprocess. In other embodiments, the needles 104 can include markings 397or transmitters that can help track the needles 104. In an embodiment,the markings can visual codes such as bar codes, quick response (QR)codes, color codes, numeric markings or any other markings which canprovide at least some identification information about the needles 104.The markings can be placed on the middle body portion of the needles104. When the needles 104 are placed in the needle trap 331, themarkings can be visually detected through the needle driver slot 349 inthe needle trap 331 by an optical sensor such as a scanner or a camera.In an embodiment, an optical needle sensor 389 can detect the markingsand the processor 383 can interpret the markings and determine theidentifications of the needles 104 based upon the markings. Thisidentification information can then be used for needle tracking andneedle reconciliation. The identification information can also be outputto the visual display 377.

In other embodiments, other mechanisms can be used for needle tracking.For example, in an embodiment the needles 104 can include embeddedelectronic components such as a radio frequency transmitter such as aradio frequency identification tag (RFID) which can transmit an RFidentification signal in response to exposure to an interrogating radiowave. In an embodiment with reference to FIG. 189, the needle sensor 389can include an interrogating radio wave transmitter and an RF receiver.When exposed to the interrogating RF waves, the RFID tags on the needles104 can emit RFID signals that can be detected by the RF receiver. TheRFID information can be transmitted to the processor 383 which can thenidentify each needle in the needle trap 331.

In other embodiments, the suture packs 101 can also have integratedtracking mechanisms. For example, the suture packs can include an activeelectronic sensor that can be activated when suture pack is opened. Thisactive signal can be transmitted to a processor off the surgical fieldthat can monitor the use of the suture packs and know which needles mustbe reconciled after the suture pack is used. In an embodiment, theseactive signals can be transmitted wirelessly from a suture pack or asuture pack sensor to a remote receiver. These active signals can beprocessed by a processor as described above. This feature can allow theneedles to be tracked from the suture packs to the needle trap in aclosed loop manner to further insure that all needles are accounted for.

In another embodiment, the tracking of the needles can be done morelocally on the barrier which can be mounted on the forearm of thesurgeon. In this embodiment, a processor can be mounted on the barrierand the processor can keep track of the locations of all needles throughout the surgical procedure. An active signal can identify a suture packthat is being opened and the identities of all of the needles in thenewly opened suture pack. The system can identify the movement of eachof the needles from the suture pack through a patient and into theneedle trap. If a needle is lost the processor that can output an errorsignal to an output device such as a visual display or audio outputdevice can immediately detect the error. If possible, the surgicalprocedure can be temporarily stopped until the lost needle is found. Thedescribed needle tracking can also provide useful needle trackinginformation that can be stored in a data center and the number ofneedles in the near surgical field can be automatically reconciled inreal time. As needles are secured in the needle trap, the system canbroadcast correlation information for needle reconciliation.

In another embodiment, the suture dispenser and needle trap can becombined onto a single mount that attaches to the proximal end of asurgical tool such as forceps. Such configurations can allow attachmentto the slotted shape of the forceps with adequate mechanical integritysuch as to avoid displacement with the mechanical forces anticipatedduring manipulation of the tools against the needle trap.

In an embodiment the suture dispenser and needle trap can be attached tothe surgical tool with a mechanical clip that secures a sufficientlength of the suture dispenser and needle trap to the tool (forceps)base to provide rotational and translational stability. In anotherembodiment, the clip can contain adhesive mounts. In another embodiment,magnets can augment the secure attachment of the suture dispenser andneedle trap to the forceps.

In other embodiments, the needle trap and/or suture dispenser can beattached to the surgical drapes covering the patient and can bepositioned adjacent to the wound. In an embodiment the suture dispenserand needle trap are mounted on a protective platform that securesposition on drapes and the platform can be secured to the drapes with anadhesive or any other suitable coupling mechanism.

The suture pack dispensers can have multiple configurations and designs.In an embodiment, suture pack dispensers can secure existing suturepacks to the barrier. In other embodiments, needles with attached sutureare secured in a structured array for easy access by the surgeon. Inanother embodiment, non pop-off suture needles are compatible with thesuture packs and suture pack dispensers. The non pop-off needles caninclude but are not limited to swaged on needles, running sutureneedles, barbed running suture needles, etc. These needles can be usedfor creating multiple surgical knots and/or for running sutureapplication that can be dispensed as single or double needles.

In an embodiment, a spool can be attached to the forearm mount orbarrier for securing the running needle. This embodiment can includemultiple spool mounts attached to the barrier for the forearmconfiguration, or to the instrument clip construct for the forcepsattached device. In an embodiment the suture spools can be stacktogether for lower profile. In another embodiment the spool can allowfor rotation for easier dispensing of the suture. Multiple mechanismsfor securing the needle, which is attached to the thread wound aroundthe spool, can includes mechanical, adhesive, magnetic mechanisms andmultiple needle enclosure designs.

Used Needle Receptacles

In many embodiments, various types of used needle receptacles can bemounted on any of the disclosed barriers and platforms. With referenceto FIG. 190, a used needle receptacle 257 can be an open top box 260with a foam 263 layer having numeric markings 259 secured within the box260. Used needles 104 can be placed in the foam 263 in a sequence andareas that correspond to the numeric markings 259. There are variousproblems with this type of used needle receptacle 257. While the distalends of the needles 104 are placed in the foam 263, the proximal end ofthe needles 14 are exposed and can be dangerous. The foam 263 can have adurometer or density that is still enough to resist displacement of theneedles 104 (angulatory and/or translatory) which potentiates injury.The needles 104 can protrude beyond the upper edge height limit of theopen top box 260 container which can create a safety issue. If thecontainer walls are higher than the needles 104, this higher height canmake the placement of the needles 104 more challenging especially whenthe box 260 is against a lateral wall. If an open top box 260 usedneedle receptacle 257 were placed on the user's arm without a barrier,the downward motion needed to stick the needle 104 into the foam 263could potentiate injury and this potential injury can be more likely ifthe surgeon tends to “swipe” the needle 104 into the surface, foam 263.A swipe needle 104 insertion can include a combination of horizontaltranslation, rotation and downward forces. The numeric markings 259 canbe small target areas that not optimal or easily hit with a used needle104 if a surgeon is trying to expedite the insertions of used needles104. Further, the small target areas associated with the numericmarkings 259 can be easily missed. There can also be a tendency toinsert a used needle 104 wherever there is an open spot on the foam 263layer rather than the designated locations. It may be better tosegregate the used needle areas on the foam 263 into limited anddistinct zones that may contain five needles 104 at most.

In an embodiment with reference to FIG. 191, it can be possible toimprove the safety of open top box 260 used needle receptacles 257 byadding a transparent dome 262 that can be coupled to multiple sides ofthe open top box 260 as well as open sides which can allow the placementof needles 104 into the foam 263. The transparent dome 262 can providemany benefits over a normal open top box 260 design. The transparentdome 262 can prevent or reduce the risk of inadvertently contactingproximal needle 104 ends which are sharp enough to tear a glove.Transparent dome 262 can also enable visual counting of the used needles104. If needles 104 are not fully fixed into the foam 263, the partialsurrounding container provided by the dome 262 makes losing a looseneedle 104 less likely. Because needles 104 are covered it can bepossible to insert a crimped proximal end of the used needle 104 intothe foam 263 (depending on durometer or density) and the dome 262 wouldprevent the sharp distal end of the needle 104 from causing injury.

In an embodiment, the box 260 with transparent dome 262 could be mountedon a platform or barrier on a forearm of a surgeon. When the used needle104 is used to install a suture and is then placed in the used needlereceptacle 257, the surgeon can hold the used needle 104 with a needledriver, place the needle 104 into the used needle receptacle 257 thoughan opening under the dome 262. The surgeon can then insert the needle104 into the foam 263 and rotate the needle driver and needle 104 tofully insert the needle 104. The initial motion of inserting the needle104 can be tangential to the forearm and there can be a lower likelihoodof missing the foam 263 and causing injury. However, there can beproblems with this configuration. Because the dome 262 makes the foam263 less accessible, it can be difficult to properly place the needles104 in an organized manner unless significant effort and attention toneedle 104 placement is performed by the surgeon. Also, the needles 104placed closest to the dome 262 opening may possibly project the proximalends out of the needle receptacle 257 from the opening which canpotentiate injury since they may not be covered by the dome 262.

In another embodiment as illustrated in FIG. 192, a used needlereceptacle 257 can have an open top box 260 that has a smaller foam 263area and can be covered by a transparent dome 262. This smaller box 260size may only allow a limited number of needles 104 to be placed in thereceptacle 257. In an embodiment, the smaller box 260 size may belimited to storing a maximum number of used needles 104, such as 5-10used needles 104. The smaller size can also allow for a Lower profiledome 262. When this used needle receptacle 257 is used, the needle 104can be placed through the opening on the side of the dome 262 androtated to drive the needle 104 into the foam 263. This insertion androtation motion can improve safety particularly when the used needlereceptacle 257 is mounted on a forearm of a surgeon. However, thesmaller size can limit the number of needles 104 that can be containedbefore the used needle receptacle 257 becomes full. Proximal ends ofneedles 104 that are stored close to the dome 262 opening can be exposedif the needle 104 is inserted at an angle into the foam 263. Dependingon the durometer or density of the foam 263 it may or may not bepossible to insert the needles 104 proximal crimped end into the foam263 given that the needle 104. The clear dome 262 can allow the needles104 to be easily counted.

With reference to FIGS. 193 and 194, another embodiment of a used needlereceptacle 257 is illustrated. In this embodiment, an open top box 260is placed within a dome 262 that is at least partially transparent.Rather than having open sides, the dome 262 can have an elongatedopening 256 that can be longer than the length of the longest needle 104to be stored. Needles 104 can be held with a needle driver and insertedthrough the elongated opening. The needle 104 can then be positionsabove the foam 263 and rotated to drive the distal end of the needle 104into the foam 263. Once the needle 104 is securely placed in the foam263, the needle 104 can be released and the needle driver can be removedfrom the elongated opening 256.

With reference to FIG. 195, an embodiment of a used needle receptacle257 can include an open top box 260 and magnets 287 mounted on a floorof the box 260. In the illustrated example a plurality of discrete diskmagnets 287 can be mounted a transparent base of the box 260 which canenable easier needle 104 counting. The spacing between adjacent magnets287 can enable magnet-free zones so that needle driver contactmagnetization is minimized. In an embodiment, the polarities of themagnets 287 poles facing outward can be alternated to also minimizemagnetization of needle drivers. When inserted, the needles 104 lie flator horizontal relative to the floor of the box 260 rather than inperpendicular orientations which can be safer because the ends of theneedles 104 may not protrude above the upper edges of the box 260. Sincethere is not an opening to insert the needle 104 though, this usedneedle receptacle 257 can accept all needle 104 sizes. It can also beeasy to use by quickly dropping needles 104 onto the magnet 287 whichwill retain the needles 104 with magnetic attraction. However, becausethe needles 104 may not be stored in any order or pattern, there can bea lack of needle 104 organization making it more difficult to count thestored needles 104. When the used needle receptacle 257 a scrubtechnician might need to take time to rearrange the needles 104 forcounting which can require additional time and more needle 104 handling.There can be additional risks of needle 104 sticks with additionalhandling. The needle 104 can often be relatively orthogonal to theneedle driver and it may be hard to appose the needles 104 with the box260. In an embodiment, the used needle receptacle 257 can be mounted onthe non-dominant forearm of a surgeon and the used needle receptacle 257can be positioned in space to facilitate needle 104 placement onto thesurface of the magnets 287.

In other embodiments, a used needle receptacle 257 can include bothmagnets 287 and foam 263. In an embodiment with reference to FIGS. 196and 197, the used needle receptacle 257 can also be oriented verticallyrelative to a forearm barrier or platform with the open top of the box260 facing proximally. In this orientation, the needle driver can placethe needle 104 substantially parallel to a planar floor of the box 260while being held by the surgeon. The needle driver can then easilyrotate so the sharp distal end of the needle 104 is driven into the foam263. The magnets 287 can allow the needles 104 to lie flat within thebox 260 in vertical orientation. The needles 104 can be inserted androtated into the foam 263. In different embodiments, the used needlereceptacle 257 can include any combination of magnets and foam. Forexample, a first embodiment can only include magnets 287, a secondembodiment, can only include foam 263 and a third embodiment can includeboth magnets 287 and foam 263. The vertical orientation of the box 260of a forearm barrier can have an improved safety aspect because theforces and motions are not directed toward the forearm. The needles 104are I insert into the box 260 and then rotated and translated into thefoam 263. The box 260 can be made of a clear material and the clearfloor of the box can allow for needle counting from both sides of thebox 260.

With reference to FIG. 198, an embodiment of a used suture needlereceptacle 257 can include a combination of magnets 287 and foam 263 invertical orientation. In the illustrated embodiment, the box 260 can bedivided into two adjacent areas. In other embodiments, the used sutureneedle receptacle 257 can include 3 or more adjacent needle storageareas. In other embodiments, the foam 263 can be angled to optimizeergonomics of the needle 104 rotation and fixation. In an embodiment, aneedle 104 can be placed on each of the spaced magnets 287 and each ofthe magnets 287 can be numbered in order to maintain needle 104organization and to facilitate needle 104 counting.

With reference to FIGS. 200 and 201 another embodiment of a used sutureneedle receptacle 257 is illustrated which can include a halfcylindrical housing 295 which can be made of a transparent material. Thehousing 295 can have a half circle shaped insertion slot. The needlescan be placed in the used suture needle receptacle 257 in a low profilearray of needles extending front to back. The used suture needlereceptacle 257 can incorporate an insertion offset zone between outeropening and foam 263 inside container housing 295. The insertion zonecan be offset from foam 263 to ensure that the entire needle 104including the proximal end is fully enclosed within the housing 295. Ifthe needle 104 is inserted at an angle into the foam 263, the proximalend of the needle 104 is less likely to extend out of the housing 295when there is a sufficient insertion offset zone.

The used suture needle receptacle 257 can be mounted on a platform withthe opening facing away from the platform. The cylindrical geometry ofthe used suture needle receptacle 257 enables the housing 295 to berotated in the mounting plate to present the foam 263 at optimal anglefor both forehand and backhand needle driver rotation which can beeasily used by both left and right handed users. The size of the openingmay provide safety features. A hand or a fingertip is less likely to beaccidentally inserted into a smaller opening than a larger opening andinjury is less likely. In an embodiment, it is possible to have a largernumber of smaller containers with each container limited to 5 needlesper housing 295. The illustrated design of the housing 295 can alloweither end of the needle 104 to be inserted into the foam 263.

With reference to FIG. 202 another embodiment of a used suture needlereceptacle 257 is illustrated. An opening in the housing 295 can have anoval entry slot that can decrease the profile of the used suture needlereceptacle 257 which can require the needle 104 to be tilted to enterthe housing 295. The illustrated embodiment can incorporate a needleentry offset zone between outer opening and foam 263 inside housing 295.The foam 263 can be mounted on a top portion of the housing that enablesneedle 104 rotation and fixation from either side of the foam 263. Foam263 material can be used that has a consistency and hardness that canallow for penetration by proximal or distal ends of the needles 104. Theneedles 104 can be inserted into the used suture needle receptacle 257in an upside down orientation. Because the exposed end of the needle 104will be below the upper surfaces of the housing 295 and close to thebarrier or platform the chances of user contact with the needle 104 areminimal. Even if a proximal end of the needle is projecting from thehousing 295 a hand would normally strike the needle with a downwardmotion and there would be little counterforce to cause the needle 104 topenetrate through a glove because the needle 104 is suspended in air.This isolation of the needle can allow lower durometer or density foamto be used which can be easier for the needles 104 to penetrate. Thisconfiguration can allow more needles 104 to be held by the used sutureneedle receptacle 257 because needles 104 can be inserted into oppositesides of the foam 263 rather than just through one side. Although theopening is illustrated as an oval shape, in other embodiments, theopening could be more triangular, tear drop or a keyhole. The wider baseof the illustrated embodiment can provide greater stability and indifferent embodiments, the used suture needle receptacle 257 can bemounted on the forearm or on the surgical field, on the patient.

With reference to FIGS. 203 and 204, an embodiment of a used sutureneedle receptacle 257 is illustrated that can have a slot slide boxhousing 295, a needle slot 349, a needle driver slot 343, a layer of topfoam 263 and a lower of bottom foam 263 on opposite sides of the needleslot 349 and an opening for inserting the used needles 104. In thisembodiment, the user can grasp the needle 104 and place the needle 104through the opening. Once the plane of the needle 104 is adjacent to thelower needle slot 349 surface the user can slide the needle 104 into thecovered portion of the needle slot 349 with the needle driver movingthrough the needle driver slot 349. The needle 104 can be compressed andheld in the needle slot 349 by the top foam 263 and bottom foam 263. Thefoam 263 on the top and bottom surface of the slot can enable insertionby both forehand and backhand needle driver rotation and either left- orright-handed needle driver use. The used suture needle receptacle 257can incorporate an insertion offset zone between outer opening and foam263 inside container. Like the needle trap embodiments, the needles 104can be organized and stored in an array in side-side orientationallowing for thin profile. Although the opening is illustrated as beinglarge and round, in other embodiments, the opening can be narrowerkeyhole shape that requires insertion and rotation through the openingbefore moving the needle 104 into the more secure needle slot 349. Theillustrated left and right needle slot 349 configuration can allow theneedles 104 to be more easily aligned and moved into the needle slot349.

With reference to FIG. 205, another embodiment of the used suture needlereceptacle 257 is illustrated. In this embodiment, the needle 104 can beplaced through a slot 256 in a housing 295 so that the distal sharp endis pressed into foam 263. The housing 295 can be coupled to an angledstructure that can help to guide the needle 104 into the foam 263.Magnets 287 can be mounted under a planar structure adjacent to the slot256 which can hold the proximal end of the needle 104 against the planarstructure so avoid having proximal end of the needle 104 positioned inspace which can

FIGS. 223-224 illustrate an embodiment of a used suture needlereceptacle 257 that can include a cylindrical housing 295 having anopening 256 on one end. An elongated foam 263 structure can be mountedto a bottom portion of the cylindrical housing 295. To store a needle104 in the receptacle 257, the needle driver can insert the needle 104into the housing until the needle is adjacent to the foam structure 263.The needle driver can then rotate the needle 104 to insert the needle104 into the foam structure 263. Once the needle 104 is securely held bythe foam 263, the needle driver can release the needle and the surgeoncan remove the needle driver from the housing 295. This insertionprocess can be described very generally as “insert and rotate” meaningthat the needle is first inserted and then rotated to secure the needle104 to the foam 263 in the receptacle 257. FIG. 225 illustrates a sideview of the housing 295. The foam 263 can be recessed within the housing295 away from the end opening 256. This offset space between the outeropening 256 and the foam 263 can be known as an “insertion offset zone”.If the needle 104 is inserted at an angle into the foam 263, theproximal end of the needle 104 is less likely to extend out of thehousing 295 when there is a sufficient insertion offset zone.

FIGS. 226-228 illustrate an embodiment of a used suture needlereceptacle 257 that is very similar to the embodiment illustrated inFIGS. 223-225. FIGS. 226 and 227 illustrate front views of thereceptacle 257 and FIG. 228 illustrates a side view. In the illustratedembodiment, the foam 263 if mounted on an upper inner surface of thehousing 295. Thus, the needle 104 must be positioned so that theinsertion end of the needle 104 is adjacent to the upper foam 263. Theplacement of the foam 263 on the upper portion of the housing 295 canhave some safety benefits. If the receptacle 257 is normally in theupright position, the needles 104 in the foam 263 will dangle downwardand gravitational forces on the needles 104 will tend to maintain thisneedle orientation. If a portion of a needle 104 extends out through theopening 256 of the housing 295, contact with the needle 104 can normallybe a downward impact which can cause the needle 104 to rotate into thedownward orientation and possibly move the exposed end of the needle 104into the housing 295. In contrast, if a portion of the needle 104 isexposed in the “lower foam” 263 embodiment, a downward impact with anexposed end can cause the needle 104 to rotate further out of thehousing 295. Further, because the portion of the needle 104 in the foam263 can provide resistance to a downward impact, contact with theexposed portion of the needle 104 can cause injury to the object thatcontacts the needle 104.

With reference to FIG. 229 a front view of another embodiment of a usedsuture needle receptacle 257 is illustrated. In this embodiment, thehousing 295 can include a transparent dome 262 and foam 263 pieces onopposite sides of the transparent dome 262. The foam 263 can includemultiple surfaces into which the needles 104 can be inserted. Thus, theneedles 104 can be inserted into any exposed surface of the foam 263pieces with either the concave or convex sides facing up. With referenceto FIG. 230 a top view of the embodiment of the used suture needlereceptacle 257 is illustrated. The foam 263 can be offset inward fromthe opening 256 in the housing 295 by the insertion offset zone for thesafety reasons described above.

With reference to FIG. 231 a side view of an embodiment of a used sutureneedle receptacle 257 which can have a cylindrical housing 295 with oneclosed end and an opening 256 which is an open end of the housing 295.FIG. 232 illustrates a front view of the embodiment of the receptacle257. An elongated strip of foam 263 can be attached to an inner surfaceof the housing 295 along the length of the housing 295. In theillustrated embodiment, the foam 263 extends out of the housing 295 andwraps around the edge of the opening 256 and along a portion of theouter surface of the housing 295. To use the receptacle 257, a needlecan be held with a needle driver such that the curvature of the needlecan be aligned with the curvature of the housing. The needle driver caninsert the needle through the opening and into the housing 295 with anend of the needle facing the foam 263. When the needle is positioned atthe desired insertion point, the needle driver can be rotated to drivethe needle into the foam 263. Once the needle is securely held by thefoam, the needle can be released by the needle driver which can then beremoved from the receptacle.

The needle traps 331 illustrated and described with reference to FIGS.223 to 232 can all utilize an insertion process can be described verygenerally as “insert and rotate.” Each of the illustrated needlereceptacles 257 can have a housing 295 having a longitudinal axis thatcan extend from the opening 256 through the center of the housing 295. Aneedle can be held with a needle driver in an orientation that isroughly perpendicular to the longitudinal axis of the needle receptacle257. The needle 104 insertion movement into the housing 295 can besubstantially parallel to the longitudinal axis. The needle 104 can beinserted until a tip of the needle 104 is aligned with a desiredinsertion point on the elastic member 263 which can be made of foam orany other suitable material. At the insertion point, the needle 104 canbe rotated about the longitudinal axis, meaning that the axis ofrotation of the needle 104 can be parallel to the longitudinal axis ofthe needle receptacles 257. The needle 104 can be inserted into theelastic member 263 to secure the needle 104 within the receptacle 257and the needle driver can release the needle 104.

With reference to FIG. 206, a plurality of used suture needlereceptacles 257 can be coupled to a movement control mechanism within ahousing 295. The housing 295 can have an opening 256 so that at leastone of used suture needle receptacle 257 can be accessible through theopening 256. In the illustrated example, the receptacles 257 move in alinear manner with the upper row moving right and the lower row movingleft. The movement can be controllably moved so that the surgeon willalways be able to place used suture needles in an empty or onlypartially full used receptacle 257 that is accessible through theopening 256. When the exposed receptacle 257 becomes full, the movementcontrol mechanism can be actuated to move an empty receptacle 257 underthe exposed opening 256. This movement also causes the full receptacleto move the used needles under a protective housing 295. This movementof the movement control mechanism can be manually powered or powered byany other movement device such as but not limited to: electric motors,pneumatic power, etc. The movement of the receptacles 257 can betriggered or actuated by various means including forces effected by thesame appendage as the one upon which it is being worn such as: elbow,wrist, hand, finger motion, etc.

With reference to FIG. 207, in another embodiment, the housing 295 canhave a cylindrical shape and the movement of the receptacles 257 can berotational. The housing 295 can have an opening 265 through whichneedles 104 can be inserted into the receptacles 257. When the exposedreceptacle 257 under the opening 265 is full, an empty receptacle 257can be rotated under the opening and the needles 104 can be moved to aposition completely within the housing 295.

In other embodiments, the needles 104 can be inserted into differentsurfaces of the used suture needle receptacles 257. For example, withreference to FIG. 208, in an embodiment, the receptacles 257 can move intranslation and rotation within the housing 295. Needle insertionsurfaces of the receptacles 257 can be accessible through an opening 256on the right side of the housing 295. Needles 104 can be inserted intoexposed surfaces of the receptacle 257. When the receptacle 257 is full,the system can move the receptacles to expose a surface of an emptyreceptacle 257 and the filled receptacle 257 can be moved within thehousing 295. In an embodiment, the receptacles 257 can be pressedagainst each other to fully contain inserted needles 104 and thiscontainment can prevent injury.

With reference to FIG. 209, in the illustrated embodiment a circularhousing 295 can have an opening 265 on an upper surface. Needles 104 canbe inserted into an exposed surface of a receptacle 257. When theexposed receptacle is full of needles 104, an empty receptacle 257 canbe rotated to be aligned with the opening 256 and the needles previouslyinserted into the full receptacle 257 can be rotated to be positionedcompletely within the housing 295 which can prevent the needles 104 fromcausing injury or being lost.

With reference to FIGS. 210-214 another embodiment of a used sutureneedle receptacle 257 is illustrated. In this embodiment, the usedsuture needle receptacle 257 can have a modular design with each unithaving a low profile and holding one or two needles 104. The housings295 of each used suture needle receptacle 257 can be transparent andfoam 263 can be secured to one side of the housing 295. In FIG. 210, oneneedle 104 has been inserted into the foam 263 at one end of the housing295 and in FIG. 211, two needles 104 have been inserted into the foam263.

With reference to FIG. 212, once a first receptacle 257 has been filled,a second receptacle 257 can be placed against the open side of the firstreceptacle 257 and once the second receptacle 257 is filled, a thirdreceptacle 257 can be placed against the open side of the secondreceptacle 257. The back surface of each receptacle 257 can be placedagainst the open side of the prior filled receptacle 257 and canfunction as a closing lid that contains the used needles 104 between theadjacent housings 295 so that the only exposed needles 104 are in theoutermost receptacle 257. In an embodiment illustrated in FIGS. 213 and214, the housings 295 of the adjacent receptacles 257 can be coupledwith hinges 288 that can be coupled to the foam 263 side edges of thehousings 295. When the receptacle 257 is filled, the next emptyreceptacle 257 can rotate about the hinge 288 until it is parallel andadjacent to the filled receptacle 257. This rotational motion can pressor flatten the position of the needle 104 into the space within thehousing 295 and the needle 104 can be contained by the adjacentreceptacle 257.

With reference to FIGS. 215 and 216 in another modular embodiment of aused suture needle receptacle 257 is illustrated. In this embodiment anopen sided box 260 which can have transparent walls and can be coupledto an elastic material 251 that covers the open side of the box 260.Needles 104 can be pressed through the elastic material 251 into achamber behind the elastic material 251. The elastic material 251 can bemade of sponge, foam or any other suitable elastic material that cansupport needles 104. When the maximum number of needles 104 have beeninserted into the elastic material 251 of the exposed receptacle 257, anempty receptacle 257 can be paced over the elastic material 251 of thefull receptacle 257. The bottom surface of the box 260 of the emptyreceptacle 257 can be pressing against the elastic material 251 of thefull receptacle 257. This compression can secure the needles 104 to thereceptacle 257 and allows the empty elastic material 251 to be availablefor more needles 104. With reference to FIG. 217 a plurality of adjacentreceptacles 257 are illustrated. In this example, three receptacles 257have been filled with needles 104 and needles 104 can be inserted intothe elastic material 251 of the fourth receptacle 257.

With reference to FIG. 218, an embodiment of a used suture needlereceptacle 257 is illustrated which can include a transparent dome 262,a magnetic 287 base and a needle slot 349 formed in an upper portion ofthe transparent dome 262. The needle slot 349 can match the curvature ofthe needle 104 and the needle slot 349 can have a larger cross sectionthan the needle 104. The used needles 104 can be inserted through theneedle slot 349 with a needle driver and released. The needles 104 canfall to the base of the needle receptacle 257 and magnets 287 in thebase can hold the needles 104 at the bottom of the receptacle 257.Needles 104 in the receptacle can be counted visually through thetransparent dome 262.

With reference to FIG. 219, another embodiment of a used suture needlereceptacle 257 is illustrated. The illustrated receptacle 257 caninclude a transparent dome 262, an internal foam 263 structure, a needleslot 349 and a needle driver slot 343. The needles 104 can be insertedthrough the needle slot 349 in the transparent dome 262 and the distalend of the needle driver can be inserted through the needle driver slot343. The needle driver can then press the needle 104 into thecylindrical foam 263 that can be mounted at the center axis of thetransparent dome 262. In other embodiments, the foam 263 can be anyother shape and mounted in any other suitable location within thetransparent dome 262. Once the needle 104 is secured to the foam 263,the needle driver can be removed from the transparent dome 262. In anembodiment, the foam 263 may be able to rotate relative to the needleslot 349 and a needle driver slot 343 so that needles 104 can beinserted around the entire perimeter of the cylindrical foam 263structure.

With reference to FIG. 220, an embodiment of a needle receptacle 257 isillustrated that has a circular housing 295 having an opening 256 and afoam disk 252 that can rotate within the circular housing 295. Needles104 can be inserted into portions of the foam disk 252 that are exposedthrough the opening 256. As the exposed area of the foam disk 252 arefilled with needles 104, the disk can be rotated within the housing 295to expose fresh portions of the foam disk 252. The used needles 104inserted into the foam disk 252 can be moved to positions that arecompletely surrounded by the housing 295 which can prevent the enclosedneedles 104 from causing injury. In an embodiment the housing 295 can betransparent so that the needles in the housing 295 can be easilycounted.

With reference to FIGS. 221 and 222, another embodiment of a needlereceptacle 257 can include housing 295 with an opening 256 and a spool453 upon which a roll of foam 265 is stored. With reference to FIG. 221,the foam 263 can be unrolled from the spool 453 and moved in closeproximity to the opening. Needles 104 can be inserted into the housing295 through the opening 256 and pressed into the exposed foam 263 whichcan securely hold the needles 104. When exposed area of foam 263 isfilled with needles 104, the spool 453 can rotate to move the needle 104filled foam 263 into the housing 295 and expose clean foam 263 as shownin FIG. 222. The illustrated process can continue until all of the foam263 has been unrolled from the spool 453.

Barrier

As discussed, the efficiency of suture installation processes can beimproved by placing used suture needles in a used needle receptacle or aused needle trap within the near surgical field. In an embodiment withreference to FIGS. 233 and 234, a used needle receptacle can be attachedto a barrier 403 wrapped around a forearm of a surgeon. In this example,the barrier 403 can be a layer of puncture resistant material that has acoupling mechanism on an inner surface of an end of the barrier 403. Thecoupling mechanism can be attached to the outer surface of the barrier403 so that the barrier 403 is securely wrapped around the forearm. FIG.233 illustrates a top view of the forearm with the needle receptacle 257attached to the barrier 403 adjacent to the dorsal portion of theforearm. FIG. 234 illustrates a side view of the forearm with the needlereceptacle 257 attached to the barrier 403 adjacent to the dorsalportion of the forearm and a suture pack 101 attached to the barrier 403adjacent to the volar portion of the forearm. In this configuration, asurgeon can remove a needle and suture from the suture pack 101 with aneedle driver, install the suture in the patient and place the usedneedle into the needle receptacle with out having the needle 104 leavethe near surgical field.

The barrier can function as a protective layer for a user and can bemade of various materials and can have various different shapes. Thebarrier can be worn over a limb of the user and can be made of anymaterial that can prevent needles from passing through the barrier andcontacting the covered limb of the user. With reference to FIG. 235 atop view of an embodiment of a barrier 403 is illustrated. The barrier403 can include a structural barrier layer 169 that can be made of amalleable and puncture resistant material such as aluminum. Grooves 404added to surface of the structural barrier layer 169 to control bendingalong preferential lines to facilitate conformability to a forearm of auser. The structural barrier layer 169 can be fabricated from a flatsheet of barrier material. This flat configuration of the barrier 403can be useful for storage and shipping because the barriers 403 can bestacked and a minimal volume of space is required for each barrier 403.

When the barrier 403 is used, a user can wrap the barrier around thelimb to be protected. In this example, the barrier 403 is designed toprotect a forearm. With reference to FIG. 236, the barrier 403 isillustrated after it has been bent to wrap around the forearm of a user.In this example, the grooves 404 can be substantially perpendicular tothe curvature of the bend(s). In the illustrated embodiment, a toolholder 147 is attached to the barrier 403.

With reference to FIG. 237, bottom view of an embodiment of a barrier403 is illustrated. The barrier 403 can include a structural barrierlayer 169 and an inner foam layer 171 can be attached to an innersurface of the structural barrier layer 169. The inner foam layer 171can be compressed against the limb of the user and this compression cancause the barrier 403 resist sliding against the limb.

With reference to FIG. 238, in an embodiment the barrier 403 can befabricated from a plastic material and the shape of the barrier 403 canbe formed into a generally cylindrical configuration. In the illustratedembodiment, the barrier 403 has a cylindrical forearm portion 415 thatfits around a forearm of a user. The hand portion 417 of the barrier 403can have a thumb hole 419. A thumb can be placed through the thumb hole419 to improve the securement of the barrier 403 on the forearm andprevent rotation movement of the barrier 403 around forearm.

In addition to providing protection, the barriers can also providemounting surfaces for various surgical components. With reference toFIGS. 239-241, an embodiment of a barrier 403 is shown upon which aneedle trap 331 and suture packs 101 are mounted. Various mountingmechanisms can be used to attached the needle trap 331 and suture packs101 to the outer surface of the barrier 403. In different embodiments,the mounting mechanisms for the needle trap 331 can be flat, low profilemounting interfaces which may be hook and loop, adhesive backed foamtape, a simple dovetail mount, clasps, barbed insert, pressure sensitiveadhesives or any other suitable coupling mechanism. In some embodiments,these same mounting mechanisms can be used to secure the suture packs101 to the barrier 403. However, in different mechanisms, differentmounting mechanisms can be used for the suture packs 101. For example,the suture packs 101 may be held to the barrier 403 with clips or anyother suitable mechanical devices.

With reference to FIGS. 242-244 another embodiment of a barrier 403 isillustrated. In the illustrated embodiment, the barrier can have acylindrical curvature. A thumb loop 420 can be attached to a distal endof the barrier 403 and a strap 121 can be attached to facing edges ofthe barrier 403. The user can place the barrier 403 on a forearm andplace a thumb through the thumb loop 420. The strap 121 can be anelastic structure that can provide sufficient tension to hold thebarrier 403 to the forearm. Needle receptacles 257 cam be mounted on adorsal portion of the barrier 403. In the illustrated embodiment, theneedle receptacles 257 can be positioned with the openings 256 facingtowards the user. Thus, the illustrated barrier 403 can be configured tobe worn on a user's left forearm. Clips 115 for holding suture packs canbe attached to the volar portion of the barrier 403. In the illustratedembodiment, a tool holder 147 for holding a tool 201 can be attached toa side of the barrier 403 that faces away from the user.

With reference to FIGS. 249, a flat pattern for an embodiment of aforearm mounted puncture barrier 403 is illustrated. The barrier 403 canhave a distal portion that includes legs 175 that can be wrapped arounda limb of the user. The width of the barrier 403 can expand towards theproximal portion of the barrier 403. The barrier 403 material can bemade of a plastic material that is flexible but the thickness anddensity of the plastic material can be sufficient to prevent the sharpssuch as used needles, tools or other objects which have one or moresharp surfaces that can puncture the skin of the patient or surgicalstaff.

In an embodiment, the barrier 403 is needle puncture resistant,unobtrusive and conformal. The barrier 403 design and fabrication can bean optimized combination of hardness and thickness. More specifically,the barrier 403 can be hard enough to resist puncture and thin enough toremain adequately flexible to be comfortable during use. In a anembodiment, the barrier 403 can be fabricated from extruded Polyethyleneterephthalate glycol-modified (PETG) or polycarbonate which can bebetween about 0.010-0.04 inch in thickness. The hardness of the barrier403 can have a hardness between about 45A and 65D (Shore hardness scaleA and D, respectively). In an embodiment, the barrier 403 can be die cutfrom flat sheet of puncture resistant material. In another embodiment,the barrier 403 can be thermo-formed in an anatomically conformal,semi-conical shape that can be attached to the forearm and adjusted tooptimize fit with a single hand. In an alternative embodiment thebarrier 403 can be blow-molded and rotationally laser cut into thedesigned shape. In different embodiments, barriers 403 can be fabricatedusing various other manufacturing processes. In an embodiment, aconformal foam layer can be mounted on inner surface of the barrier 403.This foam forearm interface surface added to the barrier can improvecomfort. In some embodiments, the barriers 403 can be packaged in a flatform. However, in other embodiments, the barriers 403 can be packaged ina rolled up configuration. The barriers 403 can be packaged with one ormore needle traps.

With reference to FIGS. 250-252 illustrate an embodiment of a method forplacing a barrier 403 on a left forearm of a user. With reference toFIG. 250, the barrier 403 can be placed over the user's forearm and thelegs 175 can be wrapped around the user's wrist. The legs 175 aresecured around the wrist and the barrier 403 can wrap around the forearmas shown in FIG. 251. The legs 175 can be secured to each other on avolar side of the wrist as shown in FIG. 252.

With reference to FIGS. 253-256 an embodiment of the barrier 403 that isplaced over a volar side of the forearm and uses hook material 127 andloop material 129 as a coupling mechanism that used to secure thebarrier 403 to the forearm. With reference to FIG. 253, a top view ofthe outer surface of the barrier 403 is illustrated. A needle trap 331and suture pack carriers 183 that hold a suture pack 101 containingsuture needles 103 are attached to the barrier 403. In an embodiment,various mechanisms can be used to attach the needle trap 331 and/orsuture pack carriers 183 to the barrier 403. The coupling mechanisms caninclude pressure sensitive adhesive (PSA) backed hook and/or loopfasteners attached to the barrier 403 to provide mounting interfaces forthe needle trap 331, suture pack mount 183, etc.

The suture pack mounts can be integrated with or coupled to the needletrap. In different embodiments, the suture pack mounts can be positionedin two orientations. A suture pack mount 183 can be positioned above theneedle trap 331 towards the radial aspect of the forearm. In anotherembodiment, a suture pack mount 183 can be positioned under the needletrap 331 in a longitudinal configuration. In an embodiment, a die cutfoam mount can be attached to an underside of the needle trap 331 withPSA. A hook or loop fastener on an underside of the foam mount can beattached to a mating fastener on the barrier 403 to increase stabilityof a suture pack 101. Alternatively, the suture pack 101 can be attachedto the needle trap 331 by means of PSA on underside of needle entry zone333. In an embodiment, a hook or loop fastener can be attached by to thebottom of the suture pack 101 which in turn attaches to a matingfastener on the outer surface of the barrier 403.

Legs 175 or straps can extend outward from the barrier 403 at a distalportion and loop material 129 can be attached to an upper surface of oneof the legs 175. With reference to FIG. 254, a bottom view of the innersurface of the barrier 403 is illustrated. Hook material 127 can beattached to the inner surface of one of the legs 175 or straps.

With reference to FIG. 255, a top view of the carrier surface supportingthe needle trap 331 and suture pack carriers 183 on the barrier 403positioned over a volar surface of a forearm is illustrated. The legs175 can wrap around the wrist to the dorsal side of the wrist. FIG. 256illustrates a bottom view of the dorsal side of the forearm over thebarrier 403 positioned over a volar surface of a forearm is illustrated.The legs 175 can be wrapped around the wrist and the loop material 129can be coupled to the hook material 127 to secure the barrier 403 to theforearm. The overlapping distal barrier strap surfaces can enableadjustment for range of forearm sizes and fit tightness.

In other embodiments a needle receptacle 257 and/or a needle trap 331can be attached to a surgical tool 201. With reference to FIGS. 245-248an embodiment of a needle receptacle 257 and suture pack clip 115assembly 206 is illustrated. FIGS. 245 and 248 illustrate perspectiveviews of the needle receptacle 257 side of the assembly 206. The needlereceptacle 257 can include a recessed surface that can include embeddedmagnets 287 that can be surrounded by a wall 200. Needles can be placedon the magnets 287 and the magnets 287 can hold the needles 104 on therecessed surface below the outer edge of the wall 200. A suture clip 115can be mounted on the opposite side of the needle receptacle 257. Withreference to FIGS. 246 and 247 illustrate bottom perspective views ofthe needle receptacle 257 and suture pack clip 115 assembly 206. Thesuture pack clip 115 can extend inward to secure a suture pack over theback surface of the needle receptacle 257.

The needle receptacle 257 and suture pack clip 115 assembly 206 can alsoinclude a tool mounting interface 433 illustrated in FIG. 245 that caninclude a tool slot 439 and a spring 245. A proximal end of a tool canbe inserted into the tool slot 439 and the spring 245 can compress thetool slot 439 against the proximal end of the tool secure the end of thetool to the needle receptacle 257 and suture pack clip 115 assembly 206.

In other embodiments, other types of needle receptacles can be attachedto surgical tool 201. An embodiment of needle trap 331 attached to aproximal end of a surgical tool 201 is illustrated in FIGS. 257-260.FIG. 257 illustrates a perspective view of a needle trap assembly 332that includes needle traps 331 that can be coupled to a tool mountinginterface 433 that is attached to a proximal end of a surgical tool 201.FIG. 258 illustrates a front view of the needle trap assembly 332. Theneedle traps 331 in the assembly 332 can function in substantially thesame ways that the needle trap 331 described above with reference toFIG. 168. The illustrated needle trap 331 can be angled towards the leftrelative to the axis of the tool 201. When needles are inserted into theneedle trap 311 the needle insertion force can apply a rotational andtranslational force on the tool 201. With reference to FIG. 259 a sideview of the needle trap assembly 332 is illustrated. In this embodiment,the needle traps 331 can be mounted on opposite sides of the toolmounting interface 433 with the entry zones 333 of the two needle traps331 facing in opposite directions. When a needle trap 331 is being used,the needle trap assembly 332 can be rotated so that the target entryzone 333 faces the needle being inserted.

With reference to FIG. 260, an exploded view of the needle trap assembly332 is illustrated. The needle traps 331 can each include an upperstructure 339 and a lower structure 341. Rotational mounting components367 can be used to attach the needle traps 331 to the tool mountinginterface 433. In the illustrated example, the rotational mountingcomponents 367 can be fastened to the holes 342 in the lower elements341 as well as the hole 434 extending through the tool mountinginterface 433. In an embodiment, the needle traps 331 can rotaterelative to the tool 201 about the holes 342 in the lower elements 341.Once the desired angular orientation of the needle traps 331 isdetermined, the rotational mounting components 367 can be tightened tolock the needle traps 331 in the desired angular orientation. In anembodiment, the needle traps 331 can have clips on portions of theneedle traps 331 that are opposite the entry zones 333.

In the illustrated embodiments, the needle traps 331 can be configuredin a back-to-back orientation. The needle traps 331 can be positioned atright angles to each other, 45 degrees off set from an axis of thesurgical tool 201. Although the tool mounting interface 433 illustratesa tool slot 439 attached to the surgical tool 201, in other embodimentsthe needle trap assembly 332 can be connected with any other types ofconnection mechanisms such as but not limited to: hook and loop, tabs,adhesives or foam etc. These various mechanisms can be used to securethe needle trap assembly 332 to various forceps geometry.

For clarity, all components of the needle traps 331 are not illustratedin FIGS. 257-260. However, in different embodiments, the needle traps331 and associated components described with reference to FIGS. 168-189can also be used with the needle trap assembly described with referenceto FIGS. 257-260.

Surgical Gown

In an embodiment, a surgical gown can be constructed with barrier ormultiple barriers built into the sleeves of the gown. Typically thesleeves of the gown are manufactured of lightweight fabric that isimpenetrable to fluids to protect surgeon and patient from crosscontamination. These gown materials however may not protect a surgeonfrom needle or sharps penetration or tearing. In an embodiment, thegowns can be created with barrier zones on the forearms that can beimpenetrable to needle perforation and can prevent tearing.

In an embodiment with reference to FIG. 261, a surgical gown 401 canhave a barrier 403 is created on the dorsal radial aspect region of thesurgical gown sleeve 402. The barrier 403 can have a curvilinear crosssection that can conform to the outer curvature of the forearm.

In another embodiment with reference to FIG. 262, sleeves 413 thatinclude barriers 403 can be separate components that can be placed overand can be removed from the gown 401. The sleeves 413 can have one ormore circumferential elastic elements 405 on the sleeve 413 in the areaof the barrier 403 that renders the sleeve conformal in the region ofthe zone and prevent rotation of the barrier 403 around the limb thatthe sleeve 403 is worn on. An elastic element 405 can also be placedaround the proximal edge of the sleeves 413 to hold the proximal portionof the sleeves 413 to the gown 401. Such elastic elements 405 canstabilize the sleeve 413 and the barrier 403 reducing movement anddisplacement as the surgeon moves.

In another embodiment the barrier 403 can be a flexible plastic shieldthat is substantially flat or slightly curved and conforms to the armwhen the barrier 403 is attached to the forearm over the surgical gown401. In other embodiments, additional straps and/or tabs can beadditionally used to augment the coupling of the forearm sleeve 413 tothe barrier 403 and improve the connection security. For example,Velcro, wet and dry adhesives, magnets and mechanical locks or any othersuitable types of connection mechanisms such tabs and straps can be usedto secure the sleeve 413 and barrier 403 to the user's forearm.

In an embodiment, the surgical gowns can be constructed of multiplepieces, panels and/or sheets of thermoplastic materials. These piecescan be seamlessly welded together to create the surgical gowns. Suchthermoplastics gown materials can be used to create zones of increasedmaterial thickness that can act as barrier zones. In an embodiment, thebarrier is comprised of a thickened layer and/or multiple layers of thegown material that can be thermally heated and compressed such that thematerial properties of the barrier prevent needle penetration withforces that one reasonably may anticipate in surgery.

With reference to FIGS. 263-265, side views of the barriers in gownsleeves 402 or separate sleeve 413 structures. With reference to FIG.263, a cross section of a barrier can be a thicker material 407 area ofthe sleeve, where the same surrounding gown material 411 is used tocreate a thicker more puncture resistant thicker material 407 whichfunctions as a barrier 403.

With reference to FIG. 264, in another embodiment the barrier 403 can bemade of a different material than the gown and the barrier 403 can bethermally welded 409 to the gown or sleeve material 411. For example, indifferent embodiments the barrier can be made of plastic, metal or anyother suitable barrier materials. The barrier 403 can be attached withadhesive to the gown sleeve material or can be mechanically attachedwith seams to the surrounding sleeve material. In this example, theintersecting edges of the barrier 403 material and the gown or sleevematerial 411 material are thermally welded 409 to each other. In otherembodiments with reference to FIG. 265, the barrier 403 material can bethermally welded to the outer surface of the gown or sleeve material411.

In other embodiments, the barriers 403 illustrated in FIGS. 263-265 canbe used as platforms for mounting other surgical devices such as needletraps, suture packs, tool holders and other objects. These componentscan be attached to the barriers with various types of connectionmechanisms such as: adhesives, magnetic mechanisms, mechanicalconnectors such as hook and loop materials, etc. For example, in anembodiment, a hook material can be attached to the bottom surface of aneedle trap and a loop material can be attached to an outer surface ofthe barrier 403. This configuration can allow the needle trap to bereleasably coupled to the barrier on a gown or a sleeve on the forearmof a surgeon.

In other embodiments, various mechanisms can be used to mechanicallyattach one or more suture packages to the barrier mounted on the forearmof a surgeon. With reference to FIG. 189, suture packs 101 and a needletrap 331 are illustrated mounted on the barrier. In similar embodiments,the barrier upon which the suture packs 101 and a needle trap 331 aremounted can be a barrier that is integrated with a sleeve or gown.

In different embodiments, the surgical gowns with barrier zones can bedisposable gowns or reusable fabric gowns. Alternatively, the gown canbe constructed of a disposable gown material with the barrier deviceattached to the forearm of the gown. However, after use, the barrier canbe removed from the disposable gown and reused. In these embodiments,the barrier can be attached to the sleeve with an adhesive, hook andloop coupling, or any other suitable releasable attachment components.

In an operating room, sterile sleeves 413 as illustrated in FIG. 262 canbe available to operating room personnel. If surgeon either tears orcontaminates the sleeve of a surgical gown, such an extra sleeve 413 canbe rolled onto the surgeon's arm. Such an overlay sleeve 413 preservessterility and covers any potential breach of the gown. The alternativeto the overlay sleeve 413 can be for the surgeon to “regown” which is aprocess in which the gown and multiple layers of gloves are removed, anew gown applied followed by new gloves. The overlay sleeve 413 thussaves time and is an efficient device where surgically appropriate. Asdiscussed, the overlay sleeve 413 can have a barrier 403 in the regionof the forearm. Such an overlay sleeve 413 can allow a barrier 403 to berapidly secured to operating room personnel.

Glove Extensions

In the operating room the surgeon can wear an operating gown thatextends to the wrist or palm of the surgeon. The surgeon can then placea glove or multiple layers of gloves on the fingers and hand can thenpulled proximally to cover the distal extent of the sleeve of the gown.Thus, a distal portion of the sleeve of the gown can be covered aproximal portion of the gloves.

FIGS. 286-289 illustrate different embodiments of surgical gloves 480.FIG. 286 illustrates a top view of an embodiment of a glove 480 having aglove portion 481 made of a latex type material that extends from thefingers to a middle portion of the forearm. A glove extension 483 can beattached to the proximal edge of the glove portion 481 and can extendfrom the forearm to a position that covers the elbow of the surgeon. Theglove extension 483 material can be made of surgical gown material orany other suitable material. FIG. 287 illustrates a top view of anembodiment of the glove 480 that has a glove portion 481 made of a latextype material that extends from the fingers to the wrist and a gloveextension portion 483 that extends from the wrist to a position thatcovers the elbow of the surgeon. With reference to FIG. 288, a top viewof a glove 480 having a glove portion 481 made of a latex type materialthat extends from the fingers to the wrist and a glove extension portion483 that extends from the wrist to a position that covers the elbow anda barrier 403 attached to a portion of the glove extension 383. FIG. 289illustrates a top view of a glove 480 having a glove portion thatextends from the finger to an elbow and a barrier 403 coupled to aportion of the glove portion 481. As discussed, the barriers 403 canprotect the portions of the forearm that are covered by the barriers403. In an embodiment, surgical components such as needle traps, needlereceptacles, suture pack carriers, tool holders, etc.

Embodiment of the present invention can include surgical gloves 481designed to extend proximally up the surgeon's forearm. Gloves 480 mayinclude a glove portion 481, a glove extension 483 and a barrier 403.The glove portion 481 can be fabricated with latex or latex likepolymers such as but not limited to: nitrile, isoprene, or vinyl. In anembodiment, a sleeve extension 483 can be coupled to the glove portion481 and the sleeve extension 483 can be made of a material that isdifferent than the glove portion 480 material covering the fingers. Morespecifically, the fingers of the glove 481 can be made of a differentmaterial than the rest of the glove. Such glove finger materials caninclude but are not limited to materials usually encountered in thesleeves of gown. Such materials include fabrics and thermoplasticmaterials.

In an embodiment, a glove can have a proximal extension 483 thatincludes a barrier 403 zone having a barrier material that can resistand/or prevent sharps from penetrating the barrier 403 and contactingthe flesh under the barrier 403. In an embodiment the glove barrier canalso allow any of the described components to be attached. For example,needle trap(s) and/or suture pack(s) can be attached to the glovebarrier using any of the described attachment mechanisms such as but notlimited to: adhesives, hook and loop connectors, magnets, mechanicalcouplings, etc.

In an embodiment, the glove with an integrated barrier can cover thehand and further comprise a proximal extension that extends over atleast a portion of the forearm and may possibly extend to the elbow. Theproximal extension can contain a barrier that can orient to the radialborder of the forearm. Such a barrier can also contain one or more zonesfor attachment of a needle trap(s) and/or suture pack(s).

In an embodiment, the barrier 403 on the forearm and integrated with theglove can comprise one or more devices that can function to provide abarrier 403 for the wearer of the glove 480. The barrier 403 materialintegrated with the glove 480 can be made of plastic, metal, fabric, orany other suitable material(s). In an embodiment the barrier 403 can beattached to an inside portion of the glove 480 which can be along theforearm. In another embodiment the barrier 403 sandwiches the glovebetween an inner and outer layer of the glove material.

Surgeon-Controlled Suture Cutting

Sutures are sometimes swaged into the trailing end of the needle andmust be cut at the conclusion of a stitch. A scrub technician maytraditionally cut the sutures from the needles. However, enabling thesurgeon to cut the sutures can eliminate the need for a third partyscrub technician to cut the suture. This procedural change can improveefficiency and safety. Ideally, the suture can be cut without impartingtension on the suture during the cutting.

In an embodiment with reference to FIGS. 266-268, scissors or a bladecan be worn on the surgeon's fingers like a ring. FIG. 266 illustrates afront view of a ring cutter 412 and FIG. 267 illustrates side view ofembodiments of the ring cutter 412. The ring cutter 412 can have a ring423 and a cutting blade 425 that can be oriented with the blade alignedwith the finger wearing the ring cutter 412. When a suture needs to becut, the surgeon can press the blade 425 against the suture to cut thesuture. The excess suture can be removed from the near surgical fieldand the ring cutter 412 can be used again when the next suture needs tobe cut. In other embodiments, a suture cutter may be incorporated intothe needle trap, or the barrier.

With reference to FIG. 268, an alternative embodiment of afinger-mounted blade 425 is illustrated. In this embodiment, the blade425 can be mounted on a distal portion of a rod 427 that can be coupledto multiple rings 423 that can be placed on a finger 429. The suturescan be cut by pressing the blade 425 against the sutures.

With reference to FIGS. 269-271, in an embodiment, a tool-mounted cutter437 can be permanently or removably attached to a proximal portion of atool 201 such as a forceps or needle driver. With reference to FIG. 269,the tool-mounted cutter 437 can have a tool cap 433 that has a recessthat can closely fit over the proximal portion of the tool 201. Theblade housing 435 can have two portions that extend proximally thatdefine a recessed area within the housing 435 where a blade 431 ismounted. In the illustrated embodiment, the blade 435 can have a “V”shaped cutting surface. With reference to FIGS. 270 and 271, the blade435 can be aligned with the length of the tool 201. When a suture needsto be cut, the surgeon can push the “V” shaped cutting surface againstthe suture to perform the cut.

In an embodiment with reference to FIGS. 272 and 273, a surgical tool201 can have an integrated cutter. In this example, standard blades 441can be mounted to the blade housing 445. The standard blades 441 caninclude mounting holes and the blades 441 can be secured to the blademounts 443 to rigidly secure the blades 441 to the blade housing 445. Inthis embodiment, the blades 431 can be removably attached to a proximalportion of a tool 201 which can be forceps, a needle driver or any othersurgical tool. When the blades 441 are worn and/or need to be replaced,the blades 431 can be removed from the blade mounts 443 and replaced.

With reference to FIG. 274, in an embodiment scissors can be mounted onthe end of the surgical tool 201. In this embodiment, the blade housing435 can include hinges 445 that can be living hinges that can allow theblades 431 to rotate and function as scissors for cutting sutures. Thehinges 445 can normally assume a straight shape so that when thescissors are normally open. In this embodiment, when the surgeon wantsto cut the suture, the suture can be placed between the blades 431. Thesurgeon can then squeeze to apply a compressive force to the sides ofthe housing 435 to move the blades 431 towards each other cut thesutures. When the compressive force applied to sides of the housing 435is released, the blades 431 of the scissors can separate and open.

With reference to FIGS. 275-278, an embodiment of a retractable cuttersystem 451 is illustrated. The retractable cutter system 451 can includea cutter 457 which can be a fixed blade 431. FIG. 275 illustrates a topview and FIG. 276 illustrates a side view of the retractable cuttersystem 451 in the retracted position. In the illustrate embodiment, thecutter 457 can have hinges 445 that allow the blades 431 to move andfunction as scissors 447. The cutter 457 can be coupled to an end of aretractable cable 455 that can be partially wrapped around a spool 453that can be coupled to a rotational spring 459. In a retracted position,the retractable cable 455 can be wrapped around the spool 453.

With reference to FIG. 277, the cable 455 can be pulled and the spool453 can rotate to allow the cable 45 to extend away from the spool 453.In an embodiment illustrated in FIG. 278, the retractable cutter system451 can be mounted to a barrier 403 on a forearm of the surgeon. Whenthe surgeon wants to cut a suture, the cutter 457 can be pulled from thespool 453 and press the blades 431 against the suture. When the sutureis cut, the surgeon can release the cutter 457 and the spring 459 canretract the cable 455 onto the spool 453.

In other embodiments with reference to FIGS. 279 and 280, sutures can becut with a barrier-mounted cutter 461 that can be integrated with aforearm-mounted barrier 403. FIG. 280 illustrates an enlarged view ofthe embodiment of the cutter 461. The cutter 461 can have a housing 463and a recessed blade(s) 431 on a distal portion of the housing 463. Theblade(s) 431 can be configured in a perpendicular orientation to thesurface of the barrier 403. When the surgeon needs to cut a suture, thesurgeon can pull the suture proximally to press the blade(s) 431 againstthe suture. In another embodiment, the barrier-mounted cutter 461 canfunction as scissors. In this embodiment, the housing 463 can becompressed against the barrier 403 to cause the blade(s) 431 to move andfunction as scissors. When the surgeon needs to cut a suture, thesurgeon can place the suture between the blade(s) 431 and the surgeoncan compress the housing 463 to actuate the scissors and cut the suture.

In other embodiments, the scissors can be actuated with a pneumaticpressure. In these embodiments, the scissors can be coupled through apneumatic hose to a control button which can be a valve and a pneumaticpressure source. The scissors can be normally open when the controlbutton is not actuated. For example, when the control button is pressedthe air pressure can be directed through a hose to actuate the pneumaticscissors and cut an object between the blades of the scissors. When thecontrol button is released, the air pressure can be vented and thepneumatic scissors can open the blades of the scissor.

In another embodiment with reference to FIG. 281, the blades 431 on adistal portion of scissors 447 can be mounted within a safety guard 465which can surround the sharp tips of the scissor blades 431 but alsohave a slot that can allow the suture to be positioned between theblades 431. The scissors 447 can be actuated by applying a compressiveforce which can cause the blades 431 to cut sutures in the slot 469 ofthe guard 465. In an embodiment, the scissors 447 can be actuated bycompressing opposite sides of the scissors 447. Alternatively, in otherembodiments the scissors can be actuated by other means such as but notlimited to: pneumatic foot pedal coupled to a piston, electronic signalfrom foot pedal, proximity sensing of suture within cutting zone. If thescissors 447 are actuated by pneumatic pressure, the pneumatic scissors447 could be coupled to a pressure source 475 and a control valve 477with a pneumatic hose.

With reference to FIGS. 282-285, an embodiment of a cutter 457 that canbe used to cut sutures is illustrated. FIG. 282 illustrates a side viewand FIG. 283 illustrates a top view of the cutter 457 in the openposition. FIG. 284 illustrates a side view and FIG. 285 illustrates atop view of the cutter 457 in the closed position. The cutter 457 caninclude a blade 431 coupled to a moveable piston 467 that slides withinthe guard 465. The guard 465 can have a hook or “J” shaped distal endportion that the blade 431 can contact to cut sutures placed into thecutting slot. The piston 467 can be normally retracted which moves theblade 431 away from the distal end portion and opens the cutting slotbetween the blade 431 and the inner end of the hook or “J” shaped distalportion. When the piston 467 is actuated the blade 431 can move into aclose fitting slot in the hook or “J” shaped distal end and a sutureplaced in the cutting slot can be cut. The piston 467 can be a pneumaticactuator that is actuated by applied air pressure supplied by apneumatic hose. Alternatively, the piston 467 can be an electricaldevice such as a solenoid that can use electromagnetic forces to actuatethe piston 467. In other embodiments, the piston 467 can be actuated bypure mechanical means.

In various embodiments the actuation of the described cutters andscissors can be accomplished by manually squeezing the scissors asdiscussed above, or by other means such as but not limited to: pneumaticfoot pedal coupled to a piston, electronic signal from foot pedal,proximity sensing of suture within cutting zone.

Needle Traps

Surgeons often pull the needle from the tissues after the “last throw”of the needle by grasping the tip portion of the needle. This practiceis common as the tip is the portion of the needle showing from thetissues and therefore the needle tip is the easiest portion of theneedle to grasp. The needle may not need to be regrasped (in a centerportion) after the last throw and therefore grasping of the tip of theneedle with the needle driver can provide the safety benefit of securingthe tip of the needle within the jaws of the needle driver. If theneedle driver and needle are handed to a scrub tech, the needle tip maynot be exposed and the needle handling can be less dangerous to thescrub tech and the surgeon. However, in embodiments, the used needlescan also be deposited in needle traps that can be configured to receiveneedles held by their tips by a needle driver.

With reference to FIGS. 290-294 an embodiment of a needle trap 331 isillustrated. FIG. 290 illustrates a cross sectional view and FIG. 291illustrates a front view of the needle trap 331. The illustrated needletrap 331 includes a housing 295 that is configured with a needle driverslot 343 that asymmetrically intersects one side of a needle slot 349,rather than the center of the needle slot 349. The needle slot 349 canhave compressible members 347 attached to one or both sides of theneedle slot 349. In an embodiment, the compressible members 347 can befoam. However in other embodiments, the compressible members 347 can bemade of any other suitable material. Further, the needle trap canutilize any other type of needle retention systems such as thosedescribed above with reference to FIGS. 172-179.

With reference to FIGS. 292 and 293 a tip of a needle driver 198 can beused to insert the needle 104 into the needle slot 349. The needledriver 198 can be moved to the end of the needle slot 349 and in thelocation the needle driver 198 can release the needle 104. Although theneedle driver 198 is illustrated with the tip portion held by the needledriver 198 can be substantially parallel with the needle driver slot343, in other embodiments the tip portion can be moved through theneedle driver slot 343 in any directional orientation. With reference toFIG. 294, illustrates the needle trap 331 after a plurality of needles104 have been inserted into the needle slot 349.

With reference to FIGS. 295 another embodiment of a needle trap 331 isillustrated. In this embodiment the needle driver slot 343 can benarrower. The tip of the needle driver 198 can have a cross section witha width that is longer than the thickness. When the needle driver 198holds a needle 104, the tip of needle driver 198 can fit within theneedle driver slot 343. However, the needle driver slot 343 can benarrower than the width of the tip of the needle driver 198 so that theneedle driver 198 cannot freely rotate within the needle driver slot343. By forcing the needle driver 198 to assume a specific rotationalorientation, the rotational positions of the needles 104 within theneedle slot 349 can also be controlled. In an embodiment, the uniformpositions of the needles 104 can increase or optimize the number ofneedles 104 that can be stored in the needle trap 331. With reference toFIG. 295 a side view of the needle trap 331 is illustrated where theneedle driver 198 has pulled a plurality of needle 104 into the needleslot 349.

Another embodiment of a needle trap 311 is illustrated in FIG. 296. Inthis embodiment, two separate needle slots 349 can be formed in thehousing 295 with the needle slots 349 positioned on opposite sides ofthe needle driver slot 343. Compressible members 347 can be secured tothe housing 295 and adjacent to each of the needle slots 349. Theneedles 104 can be inserted into either of the needle slots 349 bysliding a needle driver 198 that is grasping a needle 104 through theneedle driver slot 343.

FIG. 297 illustrates another two needle slot 349 embodiment of theneedle trap 331. In this embodiment, the needle driver slot 343 isnarrower to that the needle driver 198 cannot rotated which can causethe needles 104 to be positioned uniformly within the needle slots 249.FIG. 298 illustrates a front view of the needle trap 331.

In another embodiment with reference to FIGS. 299-306, the needle trap311 can have a circular or spiral configuration. With reference to FIG.299, embodiments of the needle driver slot 343 can be curved in acircular or spiral shape. The needle driver slot 343 can be concentricto the needle slot 349. In the illustrated example, the needle driver198 can enter the needle driver slot 343 with a needle 104. The needledriver 198 can slide through the needle driver slot 343 and pull theneedle 104 though the needle slot 343. FIG. 300 illustrates a front viewof the needle trap 331 with the needle driver 198 in the needle driverslot 347 and the needle 104 in the needle slot 349. With reference toFIG. 301, when the needle driver 198 has moved to the end of the needledriver slot 343 where the needle 104 can be released and the needledriver 198 can be pulled away from the needle trap 331. With referenceto FIG. 302, additional needles 104 can be inserted into the needle slot343 in the described manner.

Another embodiment of a circular needle trap is illustrated withreference to FIGS. 303-306. In this embodiment, the width of the needledriver slot 343 can prevent free rotation of the needle driver 198. Theneedle driver slot 343 can be slightly wider than the width of the tipof the needle driver 198. This configuration can allow a torque to beapplied between the housing 295 and the needle driver 198 which candrive the needle driver 198 through the circular portion of the needledriver slot 343. With reference to FIG. 303, the needle driver 198 canenter the needle driver slot 343 pull the needle 104 into a straightportion of the needle slot 349. FIG. 304 illustrates a front view of theneedle trap 331. With reference to FIG. 305, once the needle driver 198reaches the curved portion of the needle driver slot 343, a torque canbe applied between the needle driver 198 and the needle trap 331. Morespecifically, a clockwise torque or rotational force can be applied tothe needle driver 198 which can be resisted by a counter clockwisetorque applied to the housing 295. The torque can cause the needledriver 198 to rotate and slide in a clockwise motion through the needledriver slot 343 which can cause the needle 104 to similarly rotate andslide within the needle slot 349. With reference to FIG. 300, once theneedle driver 198 has reached the end of the needle driver slot 343, theneedle 104 can be released and the needle 198 separated from the needletrap 331. With reference to FIG. 306, the described rotational insertionprocess can be repeated for additional needles 104 until the needle trap331 is full.

For all of the needle trap embodiments illustrated in FIGS. 290-306,entrances to the needle slots 349 and needle driver slots 343 can beflared to assist with aligning the needles 104 with the needle slots349. When the needles 104 are placed in the needle slots 349, the tipsof the needles 104 can be exposed within the needle driver slot 343,which is visible from either side of the needle trap 331. However,because a portion of the housings 295 is adjacent to the tips of theneedles 104, the needle trap 331 can prevent physical contact andinjury. The needle traps 331 can also provide grooves in the housingsadjacent to the tips of the needles 104 as illustrated in FIG. 294 andin an embodiment, the tips of the needles 104 can be placed in thesegrooves to further prevent physical contact and injury.

In the illustrated embodiments, the number of needles stored in theneedle slot 349 can be determined by counting the needles within theneedle driver slot 343. In an embodiment, some or all of the housing 295components can be made of a transparent material so that a largerportion of the trapped needles 104 can be visible. In still otherembodiments, any of the compatible needle counting systems disclosedwith reference to FIGS. 180-189 can also be used with the needle trap331 embodiments illustrated in FIGS. 290-306 to perform needle counting.

In many embodiments, the needle trap 331 embodiments illustrated inFIGS. 290-306 can be secured to platforms and barriers that can bemounted or worn on limbs of surgeons. The coupling mechanisms describedfor securing the needle traps and needle receptacles to platforms andbarriers can also be applied to the needle trap 331 embodimentsillustrated in FIGS. 290-306.

FIG. 307 illustrates an exemplary embodiment of an integrated sutureneedle dispensing and securing apparatus 308. The apparatus 308comprises a needle dispensing portion 102 and a needle receptacleportion 334, supported with the same housing 309. The housing maycomprise a single structure, such as a single molded plastic piece, orthe housing may comprise a base 310 coupled to one or more covers 312.The covers may comprise separate covers for each of the needledispensing portion 102 and the needle receptacle portion 334.Alternatively, the cover may comprise a single cover for both the needledispensing portion and the needle receptacle version. The covers, or theupper portion of the housing, can comprise an optically transparentmaterial, such that the user can easily see the number of fresh needles103 or secured needles 104 supported by the apparatus 308. The needledispensing portion 102 can be configured to support one or more freshsuture needles 103, for example via a foam member 110. The new sutureneedles 103 may be pre-loaded with sutures 155, and the sutures may bedisposed within a pocket 324 of the housing 309. The needle receptacleportion 334 can be configured to receive a plurality of suture needles104, for example using the mechanisms described herein in relation toneedle receptacle 331. In many embodiments, the apparatus 308 issterile, and can be self-supporting and/or coupled to another supportsuch as a platform or a surgical tool as described herein. Providing asingle device that integrates the functions of suture needle dispensingand securing/storage can have the advantage of providing a highlycompact system for suture needle handling.

FIG. 308 is a block diagram of a sterile suturing kit 500 in accordancewith embodiments. The sterile suturing kit 500 comprises a sterileenclosure 505 containing a sterile package 101 of sterile sutures 103,and a sterile apparatus 331 for receiving at least one contaminatedsurgical suture needle 104. The sterile apparatus 331 may comprise anyneedle receptacle or sharps container as described herein, for example.The sterile needle receptacle 331 comprises a sterile housing 340 havinga top and a bottom. The needle receptacle 331 further comprises at leastone opening 350 between the top and the bottom of the housing 340,configured and dimensioned to receive a contaminated surgical needle 104inserted through the opening. The needle receptacle 331 furthercomprises a secure zone 337 within the housing, to hold the contaminatedsurgical needle 104 in a predetermined orientation with the needle tipsecured. The sterile surgical kit 500 may further comprise a protectivebarrier as described herein, configured and dimensioned to support thesterile suture package 101 and sterile needle receptacle 331. Thebarrier may, for example, be configured to be mounted to a forearm of asurgeon, as described herein.

The materials and structures to stabilize needles as described hereincan be configured in many ways. The materials and structures maycomprise one or more one or more of a deformable material, an adhesivematerial or an elastic material, and the material may comprise one ormore of a foam, elastic membrane, or an adhesive, for example.

In many embodiments, a needle resistant barrier as described herein cancomprise a thin, puncture-resistant material integrated with a flexibleweb. The barrier can comprise a plurality of bi-stable springs connectedby a flexible, in order to accommodate a range of different forearmsizes. The plurality of bi-stable springs can comprise a plurality ofstacked bi-stable springs, to adjust a compressive force.

Although the suture handling systems and methods as described herein arepresented in the context of a surgeon closing a patient's wound, thesystems and methods can be used in any situation involving the handlingof suture needles. For example, the systems and methods may be used tosafely dispense and dispose of suture needles when the dispensed sutureneedle is not used to install a suture in a patient. For example, asurgeon may dispense a fresh suture needle, and then decide that he doesnot want to use the dispensed needle. The surgeon may decide that aneedle of a different size would be more appropriate, or that thedispensed needle is not needed after all, for example. The surgeon mayaccidentally contaminate a freshly dispensed needle before the needle isused (e.g., by touching the tip of the fresh needle against an unsterilesurface), and may therefore have to dispose of the needle without usingit. A need to attend to another matter may arise after the surgeon hasalready dispensed a fresh suture needle (e.g., blood splashed onsurgeon's gloves necessitating a change of gloves), necessitating thedisposal of the fresh needle before it can be used.

The systems and methods as described herein may be used to safely handlesutures during procedures involving non-living subjects, such as duringthe performance of autopsies on cadavers, wherein the person operatingon the subject may still be exposed to blood-borne pathogens.Alternatively or in combination, the systems and methods describedherein may be used to safely handle sutures during procedures involvingnon-human subjects, such as during the performance of an operation of ananimal (e.g., in a veterinary practice or in animal studies).

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now be apparent to thoseskilled in the art without departing from the invention. It should beunderstood that various alternatives to the embodiments of the inventiondescribed herein may be employed in practicing the invention. It isintended that the following claims define the scope of the invention andthat methods and structures within the scope of these claims and theirequivalents be covered thereby.

What is claimed is:
 1. An apparatus for dispensing and storing aplurality of suture needles, the apparatus comprising: a needlereceptacle comprising: an entry zone and a secure zone; an upperstructure forming an upper portion of the secure zone; and a lowerstructure forming a lower portion of the entry zone and the secure zone,the entry zone comprising an exposed part of the lower structure and thesecure zone, the secure zone located between the upper and lowerstructures and configured to securely retain needles therein; and asuture needle dispenser coupled to the lower structure of the needlereceptacle.
 2. The apparatus of claim 1, wherein: the needle receptacleadheres to the suture needle dispenser.
 3. The apparatus of claim 1,wherein: the suture needle dispenser is coupled to the lower structureof the needle receptacle at the entry zone.
 4. The apparatus of claim 1,wherein: the upper structure comprises a transparent material so thatsuture needles stored in the secure zone can be viewed through the upperstructure.
 5. The apparatus of claim 1, wherein: the needle receptaclehas an elongate axis extending along a length of the needle receptacle,from the entry zone to the secure zone; the suture needle dispensercomprising a length, a width, and an elongate axis, the length beinggreater than the width and the elongate axis extending along the lengthof the suture needle dispenser; and the elongate axis of the needlereceptacle extending parallel to the elongate axis of the suture needledispenser.
 6. The apparatus of claim 5, wherein: the elongate axis ofthe needle receptacle extending co-linear with the elongate axis of thesuture needle dispenser.
 7. The apparatus of claim 1, wherein: a widthof the entry zone is greater than a width of the secure zone.
 8. Theapparatus of claim 1, wherein: the needle receptacle further comprises atransition zone between the entry zone and the secure zone.
 9. Theapparatus of claim 8, wherein: the upper structure forming an upperportion of the transition zone and the lower structure forming a lowerportion of the transition zone.
 10. The apparatus of claim 9, wherein: awidth of the entry zone is greater than a width of the secure zone; andthe transition zone comprising a width that reduces from the entry zoneto the secure zone.
 11. The apparatus of claim 9, wherein: the upperstructure of the transition zone comprising a flared cowling and taperedsurfaces that reduce in width and height from the entry zone to thesecure zone.
 12. The apparatus of claim 1, further comprising: aplurality of suture needles arranged in a linear arrangement along adispensing axis; and wherein the needle receptacle comprising anelongate axis extending along a length of the needle receptacle, fromthe entry zone to the secure zone, the dispensing axis being parallel tothe elongate axis of the needle receptacle.
 13. The apparatus of claim12, wherein: the dispensing axis extends co-linearly with the elongateaxis of the needle receptacle.
 14. The apparatus of claim 1, furthercomprising: a plurality of suture needles arranged in a lineararrangement along a dispensing axis; and wherein the secure zonecomprises a length that is greater than a width and an elongate axisextending along the length of the secure zone, the dispensing axis beingparallel to the elongate axis of the needle receptacle.
 15. Theapparatus of claim 14, wherein: the dispensing axis extends co-linearwith the elongate axis of the secure zone.
 16. The apparatus of claim 1,wherein: the needle receptacle and suture needle dispenser are coupledtogether with one or more of adhesive or tape.
 17. The apparatus ofclaim 16, wherein: the one or both of the needle receptacle and sutureneedle dispenser include a mounting mechanism for mounting one or bothof the needle receptacle and suture needle dispenser to a barrier. 18.The apparatus of claim 17, wherein: the mounting mechanism compriseshook and loop, adhesive backed foam tape, a dovetail mount, clasps,barbed insert, and pressure sensitive adhesives.
 19. An apparatus ofclaim 1, further comprising: a support, the needle receptacle and thesuture needle dispenser coupled to the support; and wherein the needlereceptacle comprises an opening to the secure zone formed between theupper structure and the lower structure.
 20. The apparatus of claim 19,wherein: the support comprises a mounting mechanism configured to couplethe support to a barrier.
 21. The apparatus of claim 20, wherein: themounting mechanism comprises hook and loop, adhesive backed foam tape, adovetail mount, clasps, barbed insert, and pressure sensitive adhesives.